Trial Outcomes & Findings for Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder (NCT NCT04058249)

NCT ID: NCT04058249

Last Updated: 2023-07-17

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

6 days

Results posted on

2023-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Right DLPFC aiTBS Stimulation Accelerated intermittent theta-burst stimulation over right DLPFC. Stimulation intensity standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Right DLPFC aiTBS Stimulation n=1 Participants Accelerated intermittent theta-burst stimulation over right DLPFC. Stimulation intensity standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 days

Outcome measures

Outcome measures
Measure	Right DLPFC aiTBS Stimulation n=1 Participants Accelerated intermittent theta-burst stimulation over right DLPFC. Stimulation intensity standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Number of Participants With Treatment Emergent Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Baseline, day 6

The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Right DLPFC aiTBS Stimulation n=1 Participants Accelerated intermittent theta-burst stimulation over right DLPFC. Stimulation intensity standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Young Mania Rating Scale [YMRS] Score Baseline	15 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Young Mania Rating Scale [YMRS] Score Day 6	0 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1

Adverse Events

Right DLPFC aiTBS Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Protocol Director

Stanford University

Phone: 650-800-6920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place