| CTRI Number |
CTRI/2025/03/082062 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Safer, Faster Way to Manage Anxiety: The Role of tDCS |
|
Scientific Title of Study
|
Evaluation of Safety and Efficacy of tDCS in Conjunction with Pharmacotherapy for Mild to Moderate General Anxiety Disorder (GAD): A Double-Blind, Randomized, Placebo-Controlled Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PT/24-25/001/V01/24-11-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Johnson Pradeep R |
| Designation |
HOD - Psychiatry Department |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Room F7 OPD 25 Psychiatry Department OPD Block St Johns Hospital Internal Rd John Nagar Koramangala Bengaluru Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7892673938 |
| Fax |
|
| Email |
johnson.pr@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Vardhan Gopala Krishnan |
| Designation |
HOD - Psychiatry Department |
| Affiliation |
Raja Rajeswari Medical College and Hospital |
| Address |
Room No 2, Psychiatry Department, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA
500056
India |
| Phone |
9845211970 |
| Fax |
|
| Email |
Myvish9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik M Gawali |
| Designation |
Chief Research Officer |
| Affiliation |
ClinEra Research Solutions |
| Address |
Room No 01, Research Department, First Floor, 2743, 27th Main, 15th Cross Rd, behind Domino Pizza, Bengaluru, Karnataka 560102
Hyderabad
TELANGANA
500056
India |
| Phone |
9959279640 |
| Fax |
|
| Email |
kaushik.gawali@cliniera.in |
|
|
Source of Monetary or Material Support
|
| CliniEra Research Solutions LLP, 32-80/p2/f-508, Venkateswara Lake Front, Sanik Nagar, Ramakrishnapuram, Neredmet, Hyderabad, Tirumalagiri, Telangana, India, 500056. |
| Raja Rajeswari Medical College and Hospital, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074, India |
| St Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034,
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
CLINIERA RESEARCH SOLUTIONS LLP |
| Address |
32-80/P2/F-508, Venkateshwara Lake Front, Sainik Nagar,
Ramakrishnapuram, Neredmet, Secunderabad, Hyderabd, Telangana, India - 500056 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnu Vardha Gopalakrishnan |
Raja Rajeswari Medical College and Hospital |
202, Mysore Rd, Kengeri Satellite Town, Kambipura
Bangalore
KARNATAKA |
9845211970
mywish9@gmail.com |
| Dr Johnson Pradeep R |
St. Johns Medical College Hospital |
193, 1, Hosur Rd, Santhosapuram, Koramangala Industrial Layout, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
7892673938
johnson.pr@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Rajarajeswari Medical College and Hospital – Institutional Ethics Committee |
Approved |
| St. John’s National Academy of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
A placebo is a substance or treatment which is designed to have no therapeutic value, but it is similar to active devices. A placebo will be used which is similar to the treatment device in shape, size and color, but does not provide any therapeutic benefit to the patient. |
| Intervention |
Transcranial Direct Current Stimulation (tDCS) with Binaural Beats |
A transcranial direct current stimulation device, intended to be used for treating Generalized anxiety disorder (GAD) by passing current from 0.1mA to 2.0 mA. Total duration of treatment will be 20 minutes per session. and for 25 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults, 18 to 60 years of age at the time of screening of either gender (male and female).
2. Hamilton Anxiety Rating Scale (HAM-A) score ≥ 15 (Final threshold to be determined based on study focus on moderate to severe cases)
3. Subjects must meet all the following criteria for GAD as defined by DSM-5-TR:
Excessive anxiety and worry occurring for more days, but not more than 6 months.
Difficulty controlling worry
≥ 3 of the following symptoms:
Restlessness or feeling keyed up or on edge
Being easily fatigued
Difficulty concentrating or mind going blank
Irritability
Muscle tension
Sleep disturbance
Symptoms cause clinically significant distress or impairment.
Diagnosis confirmed by licensed mental health professional
4. No change in the dosage of Psychiatric medication for ≥ 4 weeks prior to enrolment
5. No change in the Psychotherapy ≥ 4 weeks prior to enrolment.
6. There should be no change in Psychiatric medication of the subject during the complete trial period.
7. No planned medication changes during the study period
8. Subjects with ability to sign informed consent form
9. Demonstrated understanding of study nature, risks and benefits
10. Fluent in consent language
11. Willing to comply with all study procedures and follow-up
|
|
| ExclusionCriteria |
| Details |
1. Subject who participated in other study within the past 3 months.
2. Patients with a history of head trauma. Moderate to severe traumatic brain injury (TBI). Head injury requiring hospitalization. Loss of consciousness for more than 30 minutes in past 3 months. Post-concussive syndrome within past 2 years.
3. Patients with presence of metal implants in or around the head such as Cochlear implants, aneurysm clips, brain stimulators, skull plates, deep brain stimulators, shrapnel or bullet fragments, external hearing aids, any other implants in the opinion of PI hat could interfere with tDCS.
4. Patients with any history of neurological surgery such as brain surgery, neurological procedures involving skull, intracranial or cervical spine surgery, deep brain stimulation procedures.
5. Medical conditions including, cardiovascular disease (heart attacks, artery/valve related issues, arrhythmia etc.), thyroid dysfunction, active autoimmune conditions (systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disorder etc.), chronic pain requiring opioid medication.
6. Patients with history of seizure or epilepsy, on current anticonvulsant medication use.
7. Patients with suicidal tendency such as, suicide attempt, current suicidal ideation, C-SSRS and MADRS score indicating any risk, history of multiple suicide attempts.
8. Dementia or mild cognitive impairment (MMSE score less than 24)
9. Uncorrected hearing/visual impairment affecting participation as per PI opinion.
10. Comorbid conditions which are schizophrenia or psychotic disorder, bipolar disorder (Type I or II), current major depressive episode, interfering personality disorders, psychiatric hospitalization within 6 months, somatoform or dissociate disorders, eating disorders, narcolepsy.
11. Substance use disorder within past 12 months, active substance use (excluding nicotine, caffeine), and alcohol consumption more than 14 units/week within the past week.
12. Subjects undergoing chemotherapy, or with a history of chemotherapy or cancer.
13. Pregnant, breastfeeding/lactating, or planning pregnancy during the study period.
14. If a patient is already enrolled in a clinical trial
15. History of Electroconvulsive Therapy (ECT)
16. Any medical condition apart from those mentioned above which in the opinion of PI would affect the study participation. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Establishing the Safety profile of Transcranial Direct Current Stimulation in Generalized Anxiety Disorder.
Reduction in anxiety symptoms, as measured by the provided scales (HAM-A, HDRS, PSQI, K-10, C-SSRS, MADRS and VAS) in the individuals with mild and moderate GAD following the use of the tDCS device. |
Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in executive function, measured using validated neuropsychological assessments (Trail Making Part B, Mackworth Clock Test, Sternberg Task, Stop Signal Paradigm), in individuals with mild & moderate GAD after the intervention with the tDCS device. |
Baseline, 1 week, 2 weeks, 3 weeks, & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study evaluates the safety and efficacy of a transcranial direct current stimulation (tDCS) device in conjunction with pharmacotherapy for individuals with mild to moderate Generalized Anxiety Disorder (GAD). Conducted as a double-blind, randomized, placebo-controlled trial at Raja Rajeswari Medical College and St. John’s Medical College in Bengaluru, India, the study will enroll approximately 90 participants aged 18–60 years meeting DSM-5-TR criteria for GAD. Participants will be randomly assigned to receive either an active tDCS device or a non-functional placebo device for 20-minute sessions, five days a week, over three weeks, while continuing prescribed pharmacotherapy. The study will assess improvements in anxiety symptoms and executive function using tools like the Hamilton Anxiety Rating Scale (HAM-A), cognitive tasks (Trail Making Part B, Mackworth Clock Test), and Visual Analog Scales. Safety will be monitored through adverse event reporting. Exclusion criteria include severe comorbid medical or psychiatric conditions, substance use disorders, and pregnancy. Data will be analyzed using R software to establish the efficacy and safety of tDCS as an adjunct therapy for GAD. |