Review Article Available online on 15.07.2023 at http://jddtonline.info
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Open Access Full Text Article Review Article
A Systematic Review on Comparison of Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) in the Treatment of Refractory Obsessive Compulsive Disorder (OCD)
Dhivya K*1, Samuel Bibila2
1 Assistant Professor, C.L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 600097, India
2 Pharm D Student, C.L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 600097, India
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Article Info: _____________________________________________ Article History: Received 26 April 2023 Reviewed 07 June 2023 Accepted 21 June 2023 Published 15 July 2023 _____________________________________________ Cite this article as: Dhivya K, Samuel B, A Systematic Review on Comparison of Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) in the Treatment of Refractory Obsessive Compulsive Disorder (OCD), Journal of Drug Delivery and Therapeutics. 2023; 13(7):161-171 DOI: http://dx.doi.org/10.22270/jddt.v13i7.6126 _____________________________________________ *Address for Correspondence: Dr. Dhivya K, Pharm D (Ph. D), Assistant Professor, C.L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 600097, India |
Abstract _____________________________________________________________________________________________________________________ The Diagnostic and Statistical Manual of mental disorders (DSM 4) defines obsessive compulsive disorder (OCD) as compulsive or repetitive behaviors of obsessions that a person feels driven to perform. These acts and behaviors are aimed at preventing or reducing distress but are not connected in a realistic way. OCD is a pathological hypothesis of dysfunctions occurring within the cortico-striato-thalamo-cortical loops. It is one of the most prevalent and disabling psychiatric disorder associated with decreased life quality (American Psychiatric Association). This article will provide a brief study on the comparison of deep brain stimulation and transcranial magnetic stimulation in the treatment of refractory obsessive compulsive disorder besides other pharmacological and non-pharmacological treatments. Keywords: OCD, Deep brain stimulation, Transcranial magnetic stimulation |
Introduction
OCD patients are anxious, repetitive and have ritualistic behavior provoking recurrent and intrusive thoughts or obsessions. They do unwanted things like endlessly washing hands, counting steps etc., and they also think unwantedly. Some patients think that they harm their own children and some think that deadly germs are spread by them1.
Dysfunction of the serotonin system was postulated to be the main OCD factor. Serotonin plays a role in anxiety regulation, memory and sleep. The OCD patient’s receptor sites maybe impaired or blocked, preventing serotonin from reaching its full potential.
The orbitofrontal cortex, striatum and cingulate cortex in the brain are the regions most affected24. Receptors like NMDA and non-NMDA (glutamate receptors), the H2, nK1, M4 are involved in OCD. 5-HT1D, 5-HT2C and opioid receptors also mediate a secondary effect.
Some receptors are negatively correlated to the OCD’s severity whereas some are positively correlated. H2, nk1, M4, non-NMDA are positively correlated and NMDA, 5-HT1D, 5-HT1D, opioid and 5-HT2C are negatively correlated.
The diagnosis is made on the measure of Y-BOCS (Yale Brown Obsessive Compulsive Scale)22, HAM-A (Hamilton Anxiety Scale), HAM-D (Hamilton Depression rating scale), SDS work (Sheehan Disability scale domain work), SDS soc. (Sheehan disability scale domain social functioning), SDS fam. (Sheehan disability scale domain family relationships)
Total scores on the measure range from 0-40. A score of 0-7 indicates subclinical symptoms, 8-15 indicates mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms. Subscale score for obsessions and compulsions can also be measured separately.
Pharmacotherapy and Cognitive Behavioral Therapy (CBT) are effective but they have their limitations25. Pharmacotherapy has side effects such as anxiety which cause 25% patients to drop out. CBT has only partial response. 10% of patients do not respond and are severely affected. Therefore, high risk of disability and morbidity are accompanied3. The common comorbidity of OCD is the major depressive disorder leading to high suicide rate. In fact, 25% of OCD patients will attempt for suicide13. The current first line medicines are high doses of Serotonin Reuptake Inhibitors (SRI’s) or Clomipramine and psychological social treatment. Cognitive Behavioral Treatment is an asset and time escalated treatment. An assorted exhibit of anti psychotics has been utilized in the treatment but its long-term use leads to metabolic unfavorable effects restricting its utilization21.
In the last decades, Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) are introduced for the treatment of refractory OCD15.
It is one of the most successful treatment for many neurological diseases1. Nuttin et al published that DBS can be used as an anterior capsulotomy13 in OCD producing 50% improvement anterior in its symptoms8. DBS directly stimulates the target within the brain.
The technique alters the function of neural pathways11. DBS targets the internal capsule towards the anterior limb and also the subthalamic nucleus, ventral striatum, the nucleus accumbens, the inferior thalamic peduncle19.
It involves the appliance of electrodes in the brain30. Both the hemispheres are stimulated in the target area. Four electrodes are present in each lead, connected to the battery through the wire placed in abdomen or clavicle subcutaneously. The activity of the electrode is programmed externally through telemetry with a portable appliance communicating with the pulse generator. The anatomic reach of stimulation area is adjusted by stimulating the electrodes separately. Pulse, frequency, and intensity are programmable. The frequencies vary between 2-185Hz. It ranges between 60-150ms for pulse widths, current power lies between 0-10V.
Improvement in obsessions and compulsions occur within days to weeks. The response is preceded with a rapid mood elevation or hypomania8. It also improves cognitive functions in OCD patients.
The head frame is placed on head (known as streotactic head frame) before the surgery to keep the head still during brain imaging. The frame is secured to the head using surgical pins or screws. MRI is used to identify the area where the electrodes should be placed. Local anesthetic is given during the procedure. The deep brain stimulation system will be implanted by the neurosurgeon in two stages.
1. Brain Surgery:
The surgeon places a thin wire lead with electrodes into specific brain areas. The pulse generator is implanted near the collarbone. It is connected to the electrodes by means of a thin wire running under the skin.
2. Chest wall surgery:
It is the second stage of implantation in which the pulse generator near the collarbone will be programmed to send continuous impulses. The patient can turn it on and off when required using special remote control.
The exact mechanism is unknown but there are two hypotheses.
The therapeutic effect of DBS is due to the combination of indirect and direct effects on the stimulated brain. The neurons are influenced in different ways in centre of the stimulation area. Hence, the neuronal cell body is probably restrained. This restores intrinsic brain network dynamics and normalized nucleus accumbens activity.
It is a non-invasive technique that activates and modifies the neuron activity involving depolarization or hyper polarization in the axon of the neurons.
The procedure uses electromagnetic induction to induce weak electrical currents by rapidly changing the magnetic field which in turn causes electrical current on specific brain parts7. It is of interest in non-compliance, pharmacological treatment failure etc. It is also an option for refractory OCD15.
TMS produce a single pulse resulting in short responses whereas rTMS is the repetition of electromagnetic stimulations that produce repeated pulses having prolonged effects in the brain21.
It is a novel, safe technique using repetitive, brief, intense magnetic fields generated by a coil placed over the scalp that produces electric field in the underlying brain regions through electromagnetic induction. Low frequency rTms alters the activity of orbitofrontal cortex region (OFC)19.
rTms results in lasting metabolic activity changes to the stimulation sites and connected distant sites. It may modulate neural networks which are implicated in OCD. The cortico-striato-thalamo-cortical circuits are associated with OCD pathophysiology. These may include affective circuit, dorsal cognitive circuit, sensorimotor circuit and ventral cognitive circuit. Communication between these networks are associated with functions like habits, reward learning and compulsivity5. Normalizing these network activities may give relief in OCD. It may also identify the predictors of non-response like the presence of sleep disturbances etc23.
The frontostriatal circuits especially the anterior cingulate cortex and orbitofrontal cortex are associated with OCD pathophysiology. Low frequency stimulation less than or equal to 1Hz may decrease29 and high frequency stimulation greater than or equal to 5Hz increases cortical excitability of 2-3 cms region below the scalp. However, the anterior cingulated cortex, orbitofrontal cortex, caudate, putamen etc., are not accessible for rTMS stimulation. Hence they are indirectly modulated through stimulation of the superficial cortical regions that are inter connected.
Dorsolateral Prefrontal Cortex (DLPFC) and Supplementary Motor Area (SMA) are accessible through regular TMS coils and have deep connections with basal ganglia1.
Complete treatment of OCD may need upto 3 courses of sessions. They may take place over 3-6 weeks. Each session won’t be longer than 30 minutes.
The procedure alters the neural activity and excitability in the targeted brain regions. It can be excitatory or inhibitory. This is the important rationale of rTms. The brain state dependent modulating effects acts as a parameter affecting rTms.
By this factor, the treatment outcomes maybe improved in patients who develop treatment resistance and increased illness8.
Systematic review
To compare deep brain stimulation and trans cranial magnetic stimulation in the treatment of refractory OCD patients.
Systematic search in the Cochrane library, PubMed, Science direct electronic databases for studies that compared between DBS and TMS in refractory OCD. The included studies were published from 2005-2020. The search terms included are DBS in OCD patients and TMS in OCD patients. We did not find other studies in this manual search. Screening the reference list of included studies in their related websites was also done.
Inclusion and Exclusion criteria
Inclusion
Exclusion
Outcomes analyzed
Selection of studies for inclusion and data extraction
The search results were combined and duplicates were removed. Screening was done based on title and abstracts for relevance at first and then the full text was reviewed. Next, complete and careful article reviews were done to confirm those studies which described the response from DBS or TMS in the treatment of refractory OCD patients.
The studies that met the inclusion criteria were considered eligible for this systematic review.
A total of 801 studies were identified (419 in Elsevier, 2 in Cochrane library, 380 in PubMed). 443 studies were excluded after reading the titles and abstracts. 102 studies were removed because they were not specific with OCD. Some others were excluded because they did not have data (n=47), some were not published in English language (n=62), manuscripts (n=41), insufficient data (n=43) and pilot study (n=51). Finally, 12 studies met the criteria and were included in the present study.
|
S.No. |
STUDY TITLE |
AUTHOR |
OBJECTIVES |
RESULTS / CONCLUSION |
|
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12. |
Cognitive Behavioral Therapy augments the effects of DBS in OCD
Rapid effects of DBS reactivation on symptoms and neuroendocrine parameters in OCD
Three year outcomes in DBS for highly resistant OCD
Six nine year follow ups of DBS for OCD
DBS for OCD : Long term analysis of life quality
DBS of nucleus accumbens for treatment of refractory OCD
rTms improves symptoms and reduces clinical illness in patients suffering from OCD – results from a single, blind, randomized clinical trial with sham crossover condition
The effect of low frequency rTms at orbitofrontal cortex in the treatment of patients with medication refractory OCD-A retrospective open study
Sleep disturbances in OCD – Association with non response to rTms
Efficacy and clinical predictors of response to rTMS in pharmacoresistant OCD-A retrospective study
Efficacy and safety of deep TMS for OCD-A prospective multicenter randomized double blind placebo controlled trial
Use of EEG for predicting the treatment response to TMS in OCD |
M. Mantione et al
PP de Koning et al
BD Greenberg et al
Sarah M Fayad et al
Ooms P et al
Damiaan Denys et al
M. Haghhighi et al
Kumar et al
L. Donse et al
Rostami et al
Carmi et al
Metin et al |
CBT could optimize post operative management in DBS. Evaluation of CBT efficacy as deep brain augmentation was done targeted at nucleus accumbens
To evaluate rapid clinical changes (OCD, anxiety, mood) on DBS. To assess various other neuroendocrine parameters that are related to hypothalamic pituitary axis and their DBS association which induced rapid clinical changes.
To examine outcomes of DBS over 3 years in patients with severe treatment resistant OCD
To establish long term safety and effectiveness of DBS of VC/VS for adults with OCD
To determine to what extent DBS affects QOL over a period of atleast 3 years. To investigate whether the symptom improvement correlates with QOL improvement
To determine whether bilateral DBS of nucleus accumbens is an effective and safe treatment for refractory OCD
To test the hypothesis that rTms improves symptoms and resuces illness severity in patients suffering from treatment resistant OCD
To assess the safety and effectiveness of low frequency rTms (LF-rTms) over left orbitofrontal cortex (Lt-OFC) as a potential augmentation strategy in the treatment of patients with medication refractory OCD in a real world clinical setting. To examine the factors affecting response to rTms and durability of effects produced by rTms over 1 month of follow up period To compare sleep disturbances between OCD patients and healthy subjects and between rTMS responders and non responders. To determine sleep related predictors of rTMS non response
To investigate the efficacy of rTMS over two potentially involved cortical regions (ie) SMA and DLPFC for reducing OCD symptoms. To identify clinical and demographic predictors that distinguish between rTMS responders and non responders in OCD
To report results of a prospective multicenter randomized double blind study in which outcomes of dTMS targeting mPFC and Anterior Cingulate Cortex (ACC) were compared with those of sham stimulation
To assess the predictive power of quantitative EEG (qEEG)for the treatment response to right frontal TMS in OCD using a machine learning approach |
A combined treatment of DBS and CBT may be optimal for improving OCD symptoms in refractory patients
After 1 week of DBS discontinuation, reactivation results in a rapid, simultaneous +/- improvement of anxiety, depression and OCD symptoms in 8 out of 10 initial DBS responders.
Ventral capsule or ventral striatum site (VC/VS) has encouraging therapeutic effects on DBS
Reduction in OCD symptoms. Secondary outcomes excluded depressive symptoms which was increased over the follow up period. Qualitative feedback indicated DBS was well tolerated by subjects
Patient’s QOL improved in general score and in 3 of 4 WHOQOL-BREF domains. It suggests that the improvement caused by DBS is not limited to symptom reduction alone but also has a positive influence on patient’s perception of their physical, psychological, environmental and global QOL
Depression and anxiety decreased except for mild forgetfulness and word finding problems. No permanent adverse effects were reported. Bilateral DBS maybe an effective and safe treatment for refractory OCD. Both self and expert reported symptom severity reduced as compared to sham condition. Full and partial responses were observed in rTms but not in sham. This suggests that rTms is a successful intervention for patients who suffer from treatment resistant OCD
There was a decrease in mean Y-BOCS scale at the end of 20 sessions of rTMS compared with baseline (7.04 +/- 5.07; P<0.001) with no changes further during subsequent 1 month follow up period. High number of failed medication trials was found to be associated with non responses to rTMS treatment
Sleep disturbances were more prominent in OCD patients than in healthy subjects. The OCD group consisted of 12 responders and 10 non responders. The CRSD model accurately predicted non response with 83% sensitivity and 63% specificity whereas the insomnia model did not. CSRD may serve as a biomarker for different subtypes of OCD
Patient’s scores in Y-BOCS and Beck anxiety / depression inventories were decreased following rTMS treatment. There were no difference between response rates of patients in DLPFC and SMA groups. The factors “obsession severity”, “resistance”, “disturbance”, “interference due to obsessions” and “resistance against compulsions” of Y-BOCS responded to rTMS
High frequency dTMS over medial prefrontal cortex and ACC improved OCD symptoms and maybe considered for patients who do not respond to pharmacological and psychological interventions
Among four EEG bands, theta power successfully discriminated responsive from non-responsive patients. Responsive patients had more theta powers for all electrodes as compared to non responsive patients. |
12 eligible studies were conducted in America, Europe, India and Germany. A total of 357 participants with a mean age of 38.2 years, range varying between 28-68 years were included with the majority of females. The treatments used was DBS and TMS. All studies were in English language. Two studies were multicenter trials. Average follow up evaluation was 2.9 years ranging from 1-9 years.
|
CHARACTERISTICS |
NUMBER OF STUDIES |
NUMBER OF PATIENTS |
|
Total GenderMale Female Age (mean) TreatmentDBS TMS Diagnostic toolY-BOCS HAMILTON-A HAMILTON-D Study designProspective Retrospective RCT Descriptive
Follow up (mean) Publication year2006-2009 2010-2015 2016-2020
ComorbiditiesMajor depressive disorder Panic disorder Dysthymia Depression
Study location America Europe India Germany |
12
12 12 12
6 6
12 4 6
7 3 1 1
12
1 4 7
5 2 2 1
3 7 1 1 |
357
137 220 38.3 years
80 277
322 63 158
190 140 21 6
2.9 years
10 69 278
68 2 2 22
115 157 25 65 |
The summary of responders and non-responders observed in DBS :
|
SOURCE / YEAR |
TOTAL NUMBER OF PATIENTS |
RESPONDERS |
NON-RESPONDERS |
|
M. Mantione et al 2014
PP de Koning et al 2016
BD Greenberg et al 2006
Sarah M Fayad et al 2016
Ooms P et al 2013 Damiaan Denys et al 2010 |
16
15
10
6
16
16 |
9
10
8
4
After 8 months of treatment:9 After 3 years of treatment:11
9 |
7
5
2
2
After 8months : 7 After 3 years : 5
7 |
The summary of responders and non-responders observed in TMS:
|
SOURCE / YEAR |
TOTAL NUMBER OF PATIENTS |
RESPONDERS |
NON-RESPONDERS |
|
M. Haghighi et al 2015
Kumar et al 2017
L. Donse et al 2017
Rostami et al 2020
Carmi et al 2019
Metin et al 2019 |
21
25
22
65
Active treatment : 42 Sham treatment : 45
50 |
Full response : 9 Partial response : 2
13
12
30 Active treatmentFull response : 19 Partial response : 25 Sham treatmentFull response : 8 Partial response : 19
32 |
10
12
10
35 Active treatmentFull non-response : 23 Partial non-response : 17 Sham treatmentFull non-response : 37 Partial non-response : 26
18 |
Summary of adverse effects of DBS studies :
|
SOURCE |
ADVERSE EFFECTS |
|
BD Greenberg et al 2006
Sarah M Fayad et al 2016
Damiaan Denys et al 2010 |
|
Summary of adverse effects in TMS studies:
|
SOURCE |
ADVERSE EFFECTS |
|
Kumar et al 2017
Rostami et al 2020
Carmi et al 2019 |
|
This study is a compilation of the characteristics [(ie) total population, gender, age, types of treatment, diagnostic tools, study design, follow up, publication year, co-morbidities, study location] of responders and non-responders from DBS and TMS. It also includes the adverse effects occurred due to DBS and TMS from the 12 included studies. The primary objective of the study was to compare the effectiveness of DBS and TMS based upon the responses showed from refractory OCD patients. The other objectives of this study was to compare the non-responders and adverse effects due to DBS and TMS.
OCD occurs in 2-3% of the total population. It is a psychiatric disorder in which patients suffer from either obsessions or compulsions or both12. Obsessions refer to recurrent and persistent thoughts, images or impulses that are inappropriate and intrusive causing distress or anxiety. The anxiety arising due to obsessions lead to compulsions1. It is referred as behaviors that are repeated by the person or mental acts that are driven to perform1.
The standard treatment involves the combination of medication and / or psychotherapy. Primary treatment includes both Selective Serotonin Reuptake Inhibitors (SSRI’s) like fluoxetine, fluvoxamine, paroxetine, sertaline, citalopram, escitalopram and CBT. Clomipramine is a tricyclic antidepressant and it primarily acts as an SSRI11. Apart from this, neurosurgical treatments are also available. The patients who does not show any response from these treatments are known as refractory OCD patients11. The effects of the treatment are assessed with psychopathological scales which measure number of symptoms. (ie) Y-BOCS, HARS, HDRS12.
DBS delivers electrical activity of short-high frequency pulses9. The process involves implantation of electrodes in brain that produces a continuous electric pulse to modulate the specific brain areas. Leads are connected to a battery through a wire placed below clavicle or in abdomen subcutaneously. Frequencies for varying stimulation parameters are between 2-185Hz for pulse widths between 60 and 150ms for the current power between 0 and 10V1. Most patients are stimulated in the nucleus accumbens area12. The main advantage of the technique is that the effect is reversible and the stimulation parameters are adjustable10. It is effective in 57% of OCD patients12.
TMS is a non-invasive technique that activates and modifies action of neurons. rTMS uses electromagnetic induction to induce weak electrical currents through rapidly changing magnetic field that produces electrical current in general or specific brain areas. The difference between TMS and rTMS is the repetition rate of electromagnetic stimulations. Single pulse of TMS generate short responses26 and repeated pulses give prolonged effects in brain19.
From the total of 12 studies included, 6 discussed about responders and non-responders after DBS treatment and other 6 about responders and non-responders after TMS treatment.
When comparing the responders between DBS Vs TMS, it was found as 75% of responders from DBS and 61% responders from TMS, so the non-responders were 25% in DBS and 39% in TMS. When comparing the adverse effects between DBS Vs TMS, it was found that DBS showed more adverse effects than TMS. According to age DBS treatment had more geriatrics patients when compared to TMS treatment. Limitations of this study were, there are no studies revealed about the cost for these treatments and studies that shows about the adverse effects are less. These studies consists of relatively small number of patients so, we suggest that the results need to be validated through larger sample size in the future studies and more studies should be conducted to find out the adverse effects. Expert clinical skills are required to evaluate how OCD symptoms change over time.
Acknowledgement: We are grateful for the opportunity to have access to the facilities and resources provided by C.L. Baid Metha College of Pharmacy
Authors Contribution: Both authors have equal contribution
Conflict of interest: Authors has no conflict of interest
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