NCT05480124Completed
Bipolar Transcranial Alternating Current Stimulation (tACS)
Enhancing Neural Synchrony and Affective Cognitive Control in Bipolar Disorder Using Personalized Transcranial Alternating Current Stimulation (tACS)
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
The purpose of this clinical trial is to measure the safety and effectiveness of a non-invasive brain stimulation device called Transcranial Alternating Current Stimulation (tACS) in participants with bipolar disorder (BD). Participants will be asked to come in for 3 sessions. If participants qualify at the screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well as have a 30-day follow-up phone call.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 26 Jul 2022
- Start date
- 20 Apr 2023
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- University of Michigan
- Diseases
- Bipolar disorder
- NCT number
- NCT05480124
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 20 Apr 2023 to the primary completion date, 6 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant neurological abnormalities, such as seizure disorder, mass lesions, etc.
- Known Mendelian disorder
- Active problematic substance use in the past 30 days (as determined by the Substance Use Disorder module of SCID)
Other
- Evidence of suicidal intentions or behaviors in the past month, as judged by affirmative responses to question number 4 or number 5 on the Columbia Suicide Severity Rating Scale (CSSRS) or report of suicidal behaviors in the last 6 months
- Pregnant or trying to become pregnant, or currently lactating.
Who the study is looking for
- Confirmed diagnosis of BD based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria being met from previous enrollment in the Prechter Bipolar Longitudinal Study
- This study will select BD patients that scored above published norms (upper 50th percentile) on the NEO-PI impulsivity facet to ensure that the recruited patients exhibit the network dysfunction targeted by the tACS paradigm and therefore have the potential to benefit from this neuromodulation technique.
- Patients must be on a stable dose of medication for two weeks prior to Sessions 2 and 3.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.