| CTRI Number |
CTRI/2024/08/073038 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [rTMS] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To see the efficacy of deep transcranial magnetic stimulation (type of non-invasive neuromodulation) in treatment of patients with somatic symptom disorder. |
|
Scientific Title of Study
|
A double blind randomised sham controlled study for effect of deep repetitive transcranial magnetic stimulation in treatment of patients with somatic symptom disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srijana bhatta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 4096, fourth floor, Psychiatry department office, Academic block, AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
7042966365 |
| Fax |
|
| Email |
bhattasiju@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nand Kumar |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 4096, fourth floor, Psychiatry department office, Academic block, AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
9899943146 |
| Fax |
|
| Email |
nandkm2001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Srijana bhatta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 4096, fourth floor, Psychiatry department office, Academic block, AIIMS New Delhi
New Delhi DELHI 110029 India |
| Phone |
7042966365 |
| Fax |
|
| Email |
bhattasiju@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room no. 4096, Dept. of Psychiatry, All India Institute Of Medical Sciences Delhi, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srijana Bhatta |
AIIMS |
Room no 4096, Department of Psychiatry, All India Institute of Medical Sciences, Ansarinagar East, New Delhi 110029, India New Delhi DELHI |
7042966365
bhattasiju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F450||Somatization disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repetitive Transcranial Magnetic Stimulation (rTMS) |
Treatment group will receive 15 sessions of rTMS. one session/day for 15 days. Each session lasting 18 minutes. |
| Comparator Agent |
Sham rTMS |
Sham group will receive sham rTMS , one session per day for 15 days. each session lasting 18 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Somatic Symptom Disorder (SSD) according to DSM-5 criteria.
Age :- 18 - 50 years
Either gender
Registered at AIIMS Psychiatry OPD
Patients willing to give consent for the study
Poor response to pharmacotherapy |
|
| ExclusionCriteria |
| Details |
Significant comorbid psychiatric disorders
Significant medical comorbidity
History suggestive of seizures, space occupying brain lesions or
cerebrovascular accidents
Implanted device or cardiac pacemaker
History of neuromodulation including modified Electroconvulsive therapy (mECT) in the last 6 months.
Has received analgesics for a prolonged period of time |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess improvement in somatic symptoms |
at baseline and 3 weeks (post rTMS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess improvement in anxiety & depressive symptoms, quality of life & socio-occupational functioning |
at baseline & 3 weeks (post rTMS) |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Somatic Symptom Disorder (SSD) is characterized by the presence of one or more persistent somatic symptoms associated with excessive thoughts, emotions, and behaviors related to these symptoms. These symptoms may or may not be explained by medical conditions and arise from a heightened awareness of bodily sensations, with a tendency to interpret these sensations as indicative of some medical illness. Symptoms include dizziness, abdominal pain/discomfort, nausea, palpitations, headache, etc. The global prevalence of SSD is 5-7%, with a much higher female predilection, exhibiting a male-to-female ratio of 1:10 (D’Souza et al., 2022). While the etiology of SSD is unclear, studies have identified risk factors including childhood neglect, sexual abuse, chaotic lifestyle, and history of alcohol and substance abuse. Psychosocial stressors, such as unemployment and impaired occupational functioning, have also been implicated. The pathophysiology of SSD is unknown. Autonomic arousal from endogenous noradrenergic compounds may cause tachycardia, gastric hypermotility, heightened arousal, muscle tension, and pain associated with muscular hyperactivity in patients with SSD. Additionally, there may be a genetic component and environmental factors contributing to the disorder. The symptoms of SSD overlap with those of chronic pain but exhibit a distinct psychopathology. The DSM-5 classifies SSD as a separate entity, highlighting the wider range of symptoms and a preoccupation with somatic symptoms characterized by heightened sensitivity and affective-laden perception. Incorporating affective, cognitive, and behavioral components into the criteria for SSD provides a more comprehensive and accurate reflection of the true clinical picture. Failure to recognize this disorder may lead physicians to perform unnecessary2 investigations or diagnostic procedures, resulting in iatrogenic complications. It also poses a significant financial burden on healthcare services. SSD is frequently comorbid with depression and anxiety. However, the treatment outcome in SSD depends on the total number of bodily symptoms rather than the burden of comorbidities. Therefore, newer modalities of treatment must target the distinct neural circuitry of SSD.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation modality that allows for selective activation or inhibition of neural circuits . TMS works on the principle of “electromagnetic induction.†There is induction of a brief and pulsed magnetic field which is perpendicular to the electric current. Studies have shown that repeated stimulation at low frequency produces long-lasting inhibition, known as long-term depression (LTD), whereas repeated high-frequency stimulation can produce excitation through long-term potentiation (LTP). rTMS has been used to study cortical and subcortical functions, neural plasticity, and brain mapping in normal individuals and in various neuropsychiatric disorders. TMS of the dorsolateral prefrontal cortex (dlPFC) is FDA approved for treatment- resistant depression and obsessive-compulsive disorder. TMS in medically unexplained symptoms, fibromyalgia, and complex regional pain syndrome has shown encouraging results mediated by endogenous opioid-mediated functional improvement in fronto-cingulo-limbic connections. The medial PFC has been successfully targeted in depression, tinnitus, and substance use disorders to modulate anterior cingulate cortex (ACC) activity. ACC is the critical integrator where affectively laden information (insula, amygdala), visceral somatic information (thalamus, brainstem), motivated behavior (striatum, PFC, amygdala), and cognitive control (PFC) converge. Therefore, ACC can be explored as a potential candidate for neuromodulation.
Patients will be approached from AIIMS Psychiatry Outpatient setting, diagnosed with Somatic Symptom Disorder as per DSM-5 criteria. Patients meeting the inclusion criteria will be approached on the day of their visit to the OPD. Inclusion and exclusion criteria will be applied. Informed consent will be obtained from patients who agree to participate in the study. Assessment of the patients will be carried out using a short clinical performa for sociodemographic history and clinical history and then using the following instruments - Patient Health Questionnaire-15 (PHQ-15), Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), World Health Organization Quality of Life Brief Version (WHOQOL-BREF), and Global Assessment of Functioning (GAF). Assessment will be completed in one single session. The assessment will take about 1.9 hours. The patients will be randomized using the computer generated randomisations into either deep rTMS treatment group or sham rTMS group. Allocation concealment using sealed envelopes and double blinding will be done to prevent selection bias and observer bias. The patients in the treatment rTMS group will receive deep rTMS at the mPFC at 20 Hz stimulation with 50 trains of 2 seconds and an inter-train interval of 20 seconds. The protocol will take 18 minutes. Treatment sessions will be administered once daily over a period of 15 days. Conversely, patients in the sham rTMS group will undergo sham procedures for the same duration. At the conclusion of the 15-session treatment period, patients in both groups will undergo a reassessment using the aforementioned instruments to evaluate any improvements in their symptoms. |