Elucidating Neural Mechanisms of Hypo/Mania Using Theta Burst Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• All participants

‣ 18-35 years of age

⁃ Scoring less than or equal to 8 on the Hamilton Rating Scale for Depression (HRSD) at screen visit

• Participants with Bipolar Disorder (BD)

‣ Diagnosis of Bipolar Disorder I/II (BDI/II) (DSM-5 criteria) in remission (euthymic for \>2 months) or with mild-moderate hypomania

⁃ \<15 on the Young Mania Rating Scale

⁃ Not psychotic

⁃ \<3 on delusions, hallucinations, unusual thought content, and conceptual disorganization items of the Positive and Negative Syndrome Scale (PANSS)

⁃ Unmedicated or on any combination (except antidepressant monotherapy) of anxiolytics (benzodiazepines, buspirone, pregabalin, hydroxyzine) as needed, and/or atypical antipsychotics, and/or lithium, and/or other mood stabilizers, and/or non-SNRI antidepressants and/or non benzodiazepine hypnotics taken for \>2 months, as these are commonly-prescribed medications for BD

• Participants without Bipolar Disorder

‣ No present or lifetime history of BD or psychiatric disorder other than anxiety or non BD mood disorders

⁃ Not in a current depressive episode

⁃ No family history of BD

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Simona Graur, MSW, LCSW
impres@upmc.edu
412-256-8693
Time Frame
Start Date: 2021-04-06
Estimated Completion Date: 2025-11
Participants
Target number of participants: 134
Treatments
Experimental: Left ventrolateral prefrontal cortex (vlPFC)/Left SS/Left vlPFC sham
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Experimental: Left vlPFC/Left vlPFC sham/Left SS
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Experimental: Left SS/Left vlPFC sham/Left vlPFC
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Experimental: Left SS/Left vlPFC/Left vlPFC sham
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Experimental: Left vlPFC sham/Left SS/Left vlPFC
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Experimental: Left vlPFC sham/Left vlPFC/Left SS
A random number sequence will be generated for randomization of the 3 cTBS scan session order to which each participant is assigned:~* left vlPFC cTBS (cTBS applied to the left ventrolateral prefrontal cortex)~* left SS cTBS (cTBS applied to the left somatosensory area)~* left vlPFC sham TBS (go through the motions of applying cTBS to the left ventrolateral prefrontal cortex but very low current is administered so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells) Participants will know that one session will be a sham, but they will be blinded to which session is the sham.
Related Therapeutic Areas
Sponsors
Leads: Mary Phillips, MD MD (Cantab)
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov