Using brain stimulation to improve cognitive function in people with bipolar disorder
Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
This study is testing whether brain stimulation techniques can help improve thinking and memory in people with bipolar disorder who are feeling better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 14 Years to 45 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05964777 on ClinicalTrials.gov |
What this trial studies
This study explores the effects of repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS) on cognitive function in individuals with bipolar disorder who are in remission. By utilizing diffusion tensor imaging (DTI) for individualized neuronavigation, the research aims to identify abnormal functional connectivity and structural connections in specific brain regions associated with cognitive impairment. The study will assess the efficacy of these stimulation techniques in enhancing cognitive abilities and understanding the underlying neural mechanisms involved.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14-45 with a diagnosis of bipolar disorder in remission and specific cognitive deficits.
Not a fit: Patients with severe brain conditions, substance abuse issues, or those who have recently undergone similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cognitive function and quality of life for patients with bipolar disorder.
How similar studies have performed: While the combination of rTMS and tACS is a novel approach, similar studies have shown promise in using brain stimulation techniques for cognitive enhancement in various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Age 14-45 years old, regardless of gender\] 2.Meet DSM-V diagnostic criteria for bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points; 4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire PDQ≥17 points; 6.Han nationality, right-handed; 7.More than 9 years of education. Exclusion Criteria: 1. History of severe somatic or brain organic diseases and craniocerebral trauma; 2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination; 3. Those who do not cooperate or cannot effectively complete the experiment; 4. Drug, alcohol or other psychoactive substance abusers; 5. Pregnant, lactating or planned pregnancy; 6. ECT or rTMS or tACS treatment was performed within six months.
Where this trial is running
Hangzhou, Zhejiang
- Department of Psychiatry, First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: ShaoHua Hu, MD
- Email: dorhushaohua@zju.deu.cn
- Phone: 13357169115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.