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CTRI Number  CTRI/2024/10/075898 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness Of Magnetic Stimulation Of Brain In Treatment Of Insomnia Disorder. 
Scientific Title of Study   “Efficacy And Safety Of Continuous Theta Burst Stimulation Over Dorsolateral Prefrontal Cortex In Insomnia Disorder: A Randomized Sham Controlled Trial” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shobit Garg 
Designation  Professor 
Affiliation  Sri Guru Ram Rai Institute Of Medical and Health Sciences 
Address  Room No. 92, South Block, Department of Psychiatry, Sri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttarakhand 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  8958534261  
Fax    
Email  shobit.garg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobit Garg 
Designation  Professor 
Affiliation  Sri Guru Ram Rai Institute Of Medical and Health Sciences 
Address  Room No. 92, South Block, Department of Psychiatry, Sri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttarakhand 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  8958534261  
Fax    
Email  shobit.garg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neetu Garg 
Designation  Junior Resident 
Affiliation  Shri Guru Ram Rai Institute Of Medical And Health Sciences 
Address  Department Of Psychiatry,Shri Guru Ram Rai Institute of Medical And Health Sciences, Patel Nagar,Dehradun,Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  8077433188  
Fax    
Email  neetugarg246@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Rai Institute of Medical And Health Sciences,Patel Nagar,Dehradun,Uttarakhand Pin Code: 248001,India 
 
Primary Sponsor  
Name  Sri Guru Ram Rai Institute of Medical and Health Sciences 
Address  SGRRIMHS (Sri Guru Ram Rai Institute of Medical and Health Sciences), Patel Nagar, Dehradun, 248001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shobit Garg  Sri Guru Ram Rai Institute of Medical and Health Sciences  Room No. 92, South Block, Department of Psychiatry, Sri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttarakhand 248001 India
Dehradun
UTTARANCHAL 		 08958534261

shobit.garg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Shri Guru Ram Rai Institute Of Medical & Health Sciences , Patel Nagar, Dehradun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  continous theta burst magnetic stimulation  cTBS will be delivered in 3 sessions per day in right DLPFC area more than half an hour apart for 7 days . 
Comparator Agent  PLACEBO  Placebo treatment will be delivered in 3 sessions per day in right DLPFC area more than half an hour apart for 7 days . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1)Patient with a diagnosis of INSOMNIA DISORDER based on the diagnostic criteria of diagnostic and statistical manual of mental disorder, fifth edition (DSM 5)
2)Screening cut-off less than 16 as per Sleep condition indicator (SCI)
3)Patients aged above 18 years. 
4)Patient willing to participate in the study and give written consent for the same. 
 
ExclusionCriteria 
Details  1.Patient is uncooperative for the procedure.
2.Patients with neurological disorders with history of epilepsy,
organic brain damage or any neurological procedures
3.Patients with implanted metallic devices
4.Patients receiving ECT in past 6 months.
5.Patients with significant unstable medical conditions like
uncontrolled hypertension, complicated diabetes mellitus, organic
failures, etc.
6.Pregnant and lactating female.
7.Patient with mental disorder except comorbid major depressive disorder and anxiety disorders as per DSM-5 (APA, 2013)
8.Any co-morbid current substance use disorders except nicotine and caffeine as per DSM-5 (APA, 2013) 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess efficacy and safety of continuous theta burst stimulation over dorsolateral prefrontal cortex in insomnia disorder: a Randomized sham controlled trial  PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the pre-post changes in subjective sleep parameters, quality of life and safety in patients suffering from insomnia disorder following active continuous theta burst stimulation and sham continuous theta burst stimulation.  PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/12/2024 
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  

Insomnia disorder include early morning awakening, trouble falling asleep, low-quality sleep. For Sample size: As per a recent meta-analysis, the effect size of transcranial magnetic stimulation in sleep quality in primary insomnia is 0.90 . Thereby, targeting at least modest effect size of power 0.95, alpha error probability is 0.05, the number of groups is 2, and the number of measurements being 3, with a 25% dropout rate, we applied the G*Power tool, with the statistical test being ANOVA: total sample size of 30. (15 active and 15 sham). Through our study we aim at investigating the efficacy and safety of continuous theta bursts stimulation over dorsolateral prefrontal  cortex in insomnia disorder. 

 

 
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