N/A
N=13
Examining the Effect of EEG-guided Theta Burst Stimulation in Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05179785 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Brain Activity (Beta Power) in Left vLPFC — -88.78; 1437.64; 13.43; -128.00 Percentage of change post versus pre — p=0.29389090
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Theta Burst Stimulation (cTBS) (Device); Intermittent Theta Burst Stimulation (iTBS) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mary Phillips, MD MD (Cantab)
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activity (Beta Power) in Left vLPFC |
-88.78; 1437.64; 13.43; -128.00; -612.44; 89.70 | 0.29389090 |
| PRIMARY Brain Activity (Beta Power) in Right vLPFC |
-162.37; 5.13; -498.71; 131.99; -136.62; -117.6 | 0.50030946 |
| PRIMARY Brain Activity (Beta Power) in Left dlPFC |
33.83; -286.13; -623.68; 32.04; -182.53; 99.64 | 0.75298499 |
| PRIMARY Brain Activity (Beta Power) in Right dlPFC |
-128.27; -70.27; -383.76; -74.21; -83.74; -398.00 | 0.73357221 |
| PRIMARY Functional Connectivity Between Left and Right vLPFC |
-0.34; -1.84; 0.36; 3.26; -1.28; 1.07 | 0.81601415 |
| PRIMARY Functional Connectivity Between vLPFC and Other RNet Regions |
0.52; -1.03; -0.38; 3.50; 0.69; 7.03 | 0.83462055 |
| PRIMARY Functional Connectivity Between dlPFC With Other CEN Regions |
2.43; 2.03; 1.13; -0.41; 3.86; 1.44 | 0.20047055 |
| SECONDARY Brain Activity (Beta Power) in Other RNet and CEN Regions |
248.65; -55.98; 41.73; -45.54; -352.34; 928.72 | 0.86107891 |
| SECONDARY Functional Connectivity Among Other RNet and CEN Regions |
2.45; -2.10; 1.18; 2.33; 3.83; 1.27 | 0.09266386 |
| SECONDARY Immediate Choices Made on the Delay Discounting Task |
-18.47; -9.78; -26.28 | 0.0265 sig |
Summary
Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators will conduct a proof of concept study that will examine the effect of electroencephalography (EEG)-guided theta burst stimulation (TBS) on reducing mania/hypomania-related affect and reward driven behavior in adults with BD. The investigators hypothesize that TBS will reduce mania/hypomania-related affect and reward driven behavior in adults with BD.
Eligibility Criteria
Inclusion criteria
- 18-35 years of age
- Diagnosis of BD (DSM-5 criteria) in remission (euthymic for >2 months) or in a manic/hypomanic episode [manic/hypomanic or euthymic adults with BD (3-fifths manic/hypomanic); euthymic for > 2 months from most recent BD episode OR current manic/hypomanic episode]
- Not psychotic
- Score 3 units/day for the 3 days before, and/or alcohol in the last 12 hrs before, any TBS visit, confirmed at screening and scan days (to avoid TBS during alcohol withdrawal). Alcohol/nicotine/ caffeine/cannabis use (below SCID-5 SUD, binge levels) will be allowed, and used as covariates
- MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females (at the MRRC) or self-report pregnancy *Unable to understand English
- Scoring greater than or equal to 8 on HRSD at screen visit and depressive episode is confirmed on SCID-5
- Scoring greater than or equal to 18 on HRSD at any study visit
- Psychosis
- Using psychotropic medications other than those allowed in inclusion criteria
- Scoring greater than or equal to 38 on the YMRS at any study visit
- Does not provide the contact information of a medical provider (including but not limited to a PCP) that we may communicate with for any concerns of escalating symptoms of mania
Data sourced from ClinicalTrials.gov (NCT05179785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.