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CTRI Number  CTRI/2025/06/088513 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of HD-tACS in reducing cognitive symptoms in remitted bipolar patients.  
Scientific Title of Study   Efficacy of adjunct High Definition transcranial Alternating Current Stimulation (HD-tACS) for cognitive deficits in remitted patients of bipolar disorder, a randomised sham-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditya Kundu 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  Department of Psychiatry AIIMS Kalyani Saguna, NH-34 Connector, Basantapur

Nadia
WEST BENGAL
741245
India 
Phone  8584088561  
Fax    
Email  adityakundu02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukanto Sarkar 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  Department of Psychiatry AIIMS Kalyani Saguna, NH-34 Connector, Basantapur

Nadia
WEST BENGAL
741245
India 
Phone  9655489210  
Fax    
Email  sukanto.psy@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sukanto Sarkar 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Kalyani 
Address  Department of Psychiatry AIIMS Kalyani Saguna, NH-34 Connector, Basantapur

Nadia
WEST BENGAL
741245
India 
Phone  9655489210  
Fax    
Email  sukanto.psy@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Kalyani  
Address  Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 
Type of Sponsor  Research institution and hospital 
 
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 Aditya Kundu  All India Institute of Medical Sciences, Kalyani  Department of Psychiatry All India Institute of Medical Sciences, Kalyani NH-34 Connector, Basantapur, Saguna, Kalyani, West Bengal 741245
Nadia
WEST BENGAL 		 8584088561

adityakundu02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F317||Bipolar disorder, currently in remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Definition Transcranial Alternating Current Stimulation (HDtACS)  This group will receive active HD-tACS along with Treatment As Usual- Treatment as Usual (TAU) will refer to the standard and routine care, pharmacological or non-pharmacological, that was ongoing for the patient of Bipolar disorder, currently in remission as per expert psychiatrists. This group will receive gamma frequency (40Hz), Peak-to-Peak amplitude 2mA stimulation sessions over Bilateral DLPFC, 10 sessions (20 mins each). During the procedure the patient will be allowed to sit on a comfortable reclining chair. The administration of tACS will be carried out by trained medical professionals following standardized instructions.  
Comparator Agent  High Definition Transcranial Alternating Current Stimulation (HDtACS)  This group will receive sham HD-tACS along with Treatment As Usual- Treatment as Usual (TAU) will refer to the standard and routine care, pharmacological or non-pharmacological, that was ongoing for the patient of Bipolar disorder, currently in remission as per expert psychiatrists. This group will receive sham HD-tACS i.e. ramp-up and ramp-down signal for duration of 30 secs and will be turned off and kept for 20 mins. Frequency, current amplitude and stimulation area will be kept the same  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  Capacity to provide written informed consent
ICD-11 diagnosis of Bipolar disorder 1 or 2 currently in remission defined as YMRS less than 8 or HAM-D less than 7 and no change in maintenance medication by more than 50 percentage or hospitalization in the past 2 months
Patients with Addenbrooke’s Cognitive Assessment score less than 82
Right-handed patient
 
 
ExclusionCriteria 
Details  Presence of epilepsy, stroke, traumatic brain injury, dementia, or other neurodegenerative conditions
Presence of any other psychiatric disorder except tobacco use disorder
Presence of any intellectual deficits from childhood
Past history of Seizure episode
Severe vision or hearing loss that interferes with cognitive testing
Pregnancy
Patients with metallic implants in the head and neck region within 10 cm of stimulation.
Skin conditions on the scalp (e.g., eczema, psoriasis, or open wounds) that may interfere with electrode contact
Presence of implanted pacemakers, defibrillators, or neurostimulators
Prior adverse reactions to tES, tDCS, or tACS procedures
Patients who have received any neuromodulation therapy (including ECT) in the last 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome i.e. improvement or no improvement in cognition will be measured by the following:
1. NAB scores of all the domains i.e. attention, language, memory, spatial and executive function.
2. Total NAB score  		 a) Before intervention NAB Form 1 will be used
b) Immediately after the intervention NAB Form 2 will be used
c) At Week 4 (follow-up) NAB Form 1 will be used  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   01/09/2025 
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="1"
Months="3"
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   Bipolar disorder is a mood disorder characterised by emotional highs (mania or hypomania) and lows (depression). It is a severe psychiatric illness with massive psychological and social burden and with an increasing prevalence worldwide. Cognitive deficits are a prominent and well-established feature of bipolar disorder, often persisting even during euthymic periods. About 40–60% of individuals with bipolar disorder continue to experience impairments in cognitive domains such as attention, memory, executive function, and processing speed. These difficulties are observed even in patients during their first episode and tend to intensify with increasing illness duration and frequency of mood episodes. The impact of cognitive deficits contribute to about 40% of unemployment cases among individuals with bipolar disorder in the Indian population. Also, cognitive deficits increase the risk of higher relapse rates and poorer long-term functional outcomes, regardless of mood stability.  Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation method. It manipulates brains endogenous oscillations, which can affect cognition. It delivers sinusoidal alternating electric currents to the scalp to affect cortical neurons, inducing long-term synaptic plasticity. Recently, it has been also introduced in psychiatric clinical trials Dementia, Schizophrenia, OCD, ADHD and SUD and have shown promising results. So tACS is expected to have some efficacy for patients suffering from bipolar disorder currently in remission with cognitive deficits.
 
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