Efficacy of accelerated intermittent Theta Burst Stimulation (aiTBS) in improving cognitive symptoms in bipolar patients who are maintaining well

Efficacy of adjunct accelerated intermittent Theta Burst Stimulation (aiTBS) for cognitive deficits in remitted patients of bipolar disorder, a pilot randomised sham-controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111819

Enrollment

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F317- Bipolar disorder, currently in remission

Interventions

Intervention1: Accelerated Intermittent Theta Burst Stimulation (aiTBS): This group will receive active aiTBS along with Treatment As Usual- Treatment as Usual (TAU) will refer to the standard and rou

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Outcome i.e. improvement or no improvement in cognition will be measured by the following: 1. NAB (Neuropsychological Assessment Battery) scores of all the domains i.e. attention, language, memory, spatial and executive function. 2. Total NAB scoreTimepoint: 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	—

Measure

Time frame

Outcome i.e. improvement or no improvement in cognition will be measured by the following: 1. NAB (Neuropsychological Assessment Battery) scores of all the domains i.e. attention, language, memory, spatial and executive function. 2. Total NAB scoreTimepoint: 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

Measure	Time frame
Quality of Life will be assessed using Cognitive complaints in bipolar disorder rating assessment (COBRA)Timepoint: a) Week 0 (Base line) b) Week 4	—

Countries

India

Contacts

Public ContactDr Sukanto Sarkar

All India Institute of Medical Sciences, Kalyani

sukanto.psy@aiimskalyani.edu.in9655489210

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026