Efficacy of HD-tACS in reducing cognitive symptoms in remitted bipolar patients.

Phase 3

Not yet recruiting

Conditions: Bipolar disorder, currently in remission,

Registration Number: CTRI/2025/06/088513

Lead Sponsor: All India Institute of Medical Sciences, Kalyani

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome i.e. improvement or no improvement in cognition will be measured by the following:	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
1.NAB scores of all the domains i.e. attention, language, memory, spatial and executive function.	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
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 Measures

Name	Time	Method

Trial Locations

Locations (1): All India Institute of Medical Sciences, Kalyani
🇮🇳
Nadia, WEST BENGAL, India
All India Institute of Medical Sciences, Kalyani
🇮🇳Nadia, WEST BENGAL, India
Dr Aditya Kundu
Principal investigator
8584088561
adityakundu02@gmail.com