Trial Outcomes & Findings for Targeting Cerebellum to Treat Psychosis: a Transcranial Magnetic Stimulation (TMS) Study (NCT NCT02642029)

NCT ID: NCT02642029

Last Updated: 2022-12-30

Results Overview

In each trial, participants are presented with two tones separated by 1200 ms (the standard interval), a 1s delay, then a comparison pair of tones. The time interval of the second tone pair will be either equal to (E-condition), longer than (L-condition), or shorter than (S-condition) that of the first pair. Participants are asked to indicate using a keyboard whether the second time interval is equal, longer, or shorter than the first. The tones for all conditions were 700Hz in frequency, 50ms in duration, and presented binaurally via headphones. Participants completed 15 trials during each pre- or post-TMS session for a total of up to 90 total trials across the three study visits. Prior to each IDT session, participants performed a practice run consisting of six trials. The primary outcome for this task was overall accuracy (proportion of correct responses).

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

In each of the 3 study visits (separated by at least 36h), participants undergo (a) pre-TMS assessments (15-20min), (b) TMS (15min), and (c) post-TMS assessments (15-20min). Approximately 30-45 min separate the pre- and post-TMS task performances.

Results posted on

2022-12-30

Participant Flow

N=28 participants were enrolled (provided informed consent to participate in the study). (Note: when I enter the number in the "Protocol Enrollment" field, the number does not save.)

Two participants did not undergo TBS after enrollment. N=1 participant enrolled and completed the pre-intervention clinical evaluation but withdrew prior to randomization (no specific reason given by the participant). N=1 participant had a positive urine drug screen after enrollment; as active substance use within the prior 3 months is an exclusion criterion, the participant was excluded prior to randomization.

Participant milestones

Participant milestones
Measure	Sham-iTBS-cTBS Randomized first to Sham. Then randomized to iTBS for the second study visit. Then randomized to cTBS for the third study visit.	Sham-cTBS-iTBS Randomized first to Sham. Then randomized to cTBS for the second study visit. Then randomized to iTBS for the third study visit.	iTBS-sham-cTBS Randomized first to iTBS. Then randomized to sham for the second study visit. Then randomized to cTBS for the third study visit.	iTBS-cTBS-sham Randomized first to iTBS. Then randomized to cTBS for the second study visit. Then randomized to sham TBS for the third study visit.	cTBS-sham-iTBS Randomized first to cTBS. Then randomized to sham for the second study visit. Then randomized to iTBS for the third study visit.	cTBS-iTBS-sham Randomized first to cTBS. Then randomized to iTBS for the second study visit. Then randomized to sham TBS for the third study visit.
Study Visit 1 (1 Day) STARTED	6	5	3	4	4	4
Study Visit 1 (1 Day) COMPLETED	6	5	3	4	4	4
Study Visit 1 (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout 1 (≥ 36 Hours) STARTED	6	5	3	4	4	4
Washout 1 (≥ 36 Hours) COMPLETED	5	4	3	4	3	4
Washout 1 (≥ 36 Hours) NOT COMPLETED	1	1	0	0	1	0
Study Visit 2 (1 Day) STARTED	5	4	3	4	3	4
Study Visit 2 (1 Day) COMPLETED	4	4	3	4	3	4
Study Visit 2 (1 Day) NOT COMPLETED	1	0	0	0	0	0
Washout 2 (≥ 36 Hours) STARTED	4	4	3	4	3	4
Washout 2 (≥ 36 Hours) COMPLETED	2	4	3	4	3	4
Washout 2 (≥ 36 Hours) NOT COMPLETED	2	0	0	0	0	0
Study Visit 3 (1 Day) STARTED	2	4	3	4	3	4
Study Visit 3 (1 Day) COMPLETED	2	4	3	4	3	4
Study Visit 3 (1 Day) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham-iTBS-cTBS Randomized first to Sham. Then randomized to iTBS for the second study visit. Then randomized to cTBS for the third study visit.	Sham-cTBS-iTBS Randomized first to Sham. Then randomized to cTBS for the second study visit. Then randomized to iTBS for the third study visit.	cTBS-sham-iTBS Randomized first to cTBS. Then randomized to sham for the second study visit. Then randomized to iTBS for the third study visit.
Washout 1 (≥ 36 Hours) Adverse Event	1	0	0
Washout 1 (≥ 36 Hours) Withdrawal by Subject	0	1	0
Washout 1 (≥ 36 Hours) Protocol violation: Excluded due to change in psychiatric medications	0	0	1
Study Visit 2 (1 Day) Adverse Event	1	0	0
Washout 2 (≥ 36 Hours) Adverse Event	1	0	0
Washout 2 (≥ 36 Hours) Excluded due to hospitalization for substance misuse	1	0	0

Baseline Characteristics

Targeting Cerebellum to Treat Psychosis: a Transcranial Magnetic Stimulation (TMS) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=28 Participants All enrolled participants (study was designed for all participants to receive all 3 interventions- iTBS, cTBS, and sham TBS).
Age, Continuous	31.8 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 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	3 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	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Diagnosis Schizophrenia	6 Participants n=5 Participants
Diagnosis Schizoaffective disorder	12 Participants n=5 Participants
Diagnosis Bipolar disorder with psychotic features	10 Participants n=5 Participants
Education High School/GED	6 Participants n=5 Participants
Education Part-college or 2-year college	10 Participants n=5 Participants
Education College/bachelor's degree	8 Participants n=5 Participants
Education Graduate/professional school	4 Participants n=5 Participants
Estimated Intelligence Quotient (IQ) [(North American Adult Reading Test (NAART)] Verbal IQ	118.3 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants
Estimated Intelligence Quotient (IQ) [(North American Adult Reading Test (NAART)] Performance IQ	114.5 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants
Estimated Intelligence Quotient (IQ) [(North American Adult Reading Test (NAART)] Full scale IQ	118.7 units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) PANSS, total	41.0 units on a scale STANDARD_DEVIATION 27.3 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) PANSS, positive	9.8 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) PANSS, negative	10.4 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants
Positive and Negative Syndrome Scale (PANSS) PANSS, general psychopathology	20.9 units on a scale STANDARD_DEVIATION 13.5 • n=5 Participants
Young Mania Rating Scale (YMRS)	7.3 units on a scale STANDARD_DEVIATION 9.3 • n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	10.9 units on a scale STANDARD_DEVIATION 11.2 • n=5 Participants
Psychotic Symptom Rating Scale (PSYRATS-AH)	4.1 units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants
Chlorpromazine equivalent dose (CPZ)	242.4 mg/day STANDARD_DEVIATION 311.6 • n=5 Participants
Taking antipsychotic medication	17 Participants n=5 Participants
Taking mood stabilizer	14 Participants n=5 Participants
Taking either antipsychotic or mood stabilizer	23 Participants n=5 Participants
Not taking any psychotropic medication	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: In each of the 3 study visits (separated by at least 36h), participants undergo (a) pre-TMS assessments (15-20min), (b) TMS (15min), and (c) post-TMS assessments (15-20min). Approximately 30-45 min separate the pre- and post-TMS task performances.

Population: Cross-over design in which patients were assigned to 3 sessions of cerebellar TBS: one session each of iTBS, cTBS, and sham TBS. Analyses were conducted for all participants (patients who completed at least one study visit; n=26) as well as for completers only (patients who completed all 3 study visits; n=20; results not reported here). The fields for "overall number of participants analyzed" (above) indicate all participants who completed each of the sessions (iTBS, cTBS, sham TBS).

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Accuracy of Time Interval Discrimination Pre- and Post-TMS Pre-TBS	.503 accuracy (proportion correct) Standard Deviation .156	.521 accuracy (proportion correct) Standard Deviation .183	.456 accuracy (proportion correct) Standard Deviation .141
Change (Δ) in Accuracy of Time Interval Discrimination Pre- and Post-TMS Post-TBS	.479 accuracy (proportion correct) Standard Deviation .128	.514 accuracy (proportion correct) Standard Deviation .145	.525 accuracy (proportion correct) Standard Deviation .174
Change (Δ) in Accuracy of Time Interval Discrimination Pre- and Post-TMS Change in accuracy (post-pre)	-.024 accuracy (proportion correct) Standard Deviation .175	-.006 accuracy (proportion correct) Standard Deviation .163	.069 accuracy (proportion correct) Standard Deviation .198

PRIMARY outcome

Participants are presented with a series of words or numbers and prompted to indicate as quickly as possible whether the currently presented stimulus is the same as the one presented n-stimuli previously. For example, in a 2-back task a subject would be asked to indicate whether the current stimulus was identical to that presented 2 stimuli before. To increase the likelihood of detecting change in task performance with each TMS condition (and minimize potential ceiling or floor effects), the difficulty level was individualized so that each participant performed at approximately 80% accuracy; during the "pre" session of the first study visit, a trial session established the difficulty level, i.e., how many presentations back (n-stimuli) at which the task would start. After the trial session, a session with 50 presentations was carried out and recorded whether the response was correct (accuracy) and the time from presentation to response (reaction time).

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Accuracy of N-back Working Memory Task Pre- and Post-TMS Pre-TBS	0.780 accuracy (proportion correct) Standard Error 0.0144	0.753 accuracy (proportion correct) Standard Error 0.0156	0.775 accuracy (proportion correct) Standard Error 0.0143
Change (Δ) in Accuracy of N-back Working Memory Task Pre- and Post-TMS Post-TBS	0.795 accuracy (proportion correct) Standard Error 0.0138	0.778 accuracy (proportion correct) Standard Error 0.0147	0.784 accuracy (proportion correct) Standard Error 0.0139
Change (Δ) in Accuracy of N-back Working Memory Task Pre- and Post-TMS Ratio (post/pre)	1.10 accuracy (proportion correct) Standard Error .074	1.15 accuracy (proportion correct) Standard Error .077	1.05 accuracy (proportion correct) Standard Error .065

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Reaction Time (RT) of N-back Working Memory Task Pre- and Post-TMS Pre-TBS	831 ms Standard Error 13.29	862 ms Standard Error 14.62	901 ms Standard Error 11.63
Change (Δ) in Reaction Time (RT) of N-back Working Memory Task Pre- and Post-TMS Post-TBS	817 ms Standard Error 10.66	886 ms Standard Error 10.80	877 ms Standard Error 9.16
Change (Δ) in Reaction Time (RT) of N-back Working Memory Task Pre- and Post-TMS Change in RT (post-pre)	-14 ms Standard Error 8.90	24.0 ms Standard Error 11.46	-23.8 ms Standard Error 7.41

PRIMARY outcome

Participants will take a brief computerized survey pre- and post-TMS, in which they will be presented with visual analogue scales (VAS, range 0-100, 0=absent, 100=most severe) and asked to indicate current levels of depression, anxiety, euphoria, auditory hallucinations, visual hallucinations, paranoia, referential thinking, and delusions of control. The VAS format will allow participants to self-report ratings quickly and easily with simple mouse clicks.

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Depressed Mood) Pre-TBS	22.5 score on a scale Interval 0.0 to 70.0	37 score on a scale Interval 0.0 to 91.0	16 score on a scale Interval 0.0 to 70.0
Change (Δ) in Symptoms (Depressed Mood) Post-TBS	19.5 score on a scale Interval 0.0 to 72.0	42 score on a scale Interval 0.0 to 71.0	4 score on a scale Interval 0.0 to 76.0
Change (Δ) in Symptoms (Depressed Mood) Change in VAS score (post-pre)	0 score on a scale Interval -31.0 to 63.0	0 score on a scale Interval -41.0 to 26.0	0 score on a scale Interval -43.0 to 7.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Anxiety) Pre-TBS	22 score on a scale Interval 0.0 to 73.0	50 score on a scale Interval 0.0 to 87.0	23 score on a scale Interval 0.0 to 74.0
Change (Δ) in Symptoms (Anxiety) Post-TBS	4 score on a scale Interval 0.0 to 75.0	30 score on a scale Interval 0.0 to 77.0	5 score on a scale Interval 0.0 to 73.0
Change (Δ) in Symptoms (Anxiety) Change in VAS score (post-pre)	-2.5 score on a scale Interval -50.0 to 24.0	-1 score on a scale Interval -40.0 to 32.0	0 score on a scale Interval -30.0 to 22.0

PRIMARY outcome

Participants will take a brief computerized survey pre- and post-TMS, in which they will be presented with visual analogue scales (VAS, range 0-100, 0=absent/no elation, 100=most severe) and asked to indicate current levels of depression, anxiety, euphoria, auditory hallucinations, visual hallucinations, paranoia, referential thinking, and delusions of control. Higher VAS scores for elation indicate more elation (suggestive of mania). The VAS format will allow participants to self-report ratings quickly and easily with simple mouse clicks.

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Elated Mood) Pre-TBS	6 score on a scale Interval 0.0 to 54.0	2 score on a scale Interval 0.0 to 51.0	1 score on a scale Interval 0.0 to 53.0
Change (Δ) in Symptoms (Elated Mood) Post-TBS	8.5 score on a scale Interval 0.0 to 60.0	0 score on a scale Interval 0.0 to 57.0	1 score on a scale Interval 0.0 to 40.0
Change (Δ) in Symptoms (Elated Mood) Change in VAS score (post-pre)	0 score on a scale Interval -54.0 to 49.0	0 score on a scale Interval -24.0 to 51.0	0 score on a scale Interval -50.0 to 37.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Auditory Hallucinations) Pre-TBS	0 score on a scale Interval 0.0 to 65.0	0 score on a scale Interval 0.0 to 50.0	0 score on a scale Interval 0.0 to 70.0
Change (Δ) in Symptoms (Auditory Hallucinations) Post-TBS	0 score on a scale Interval 0.0 to 49.0	0 score on a scale Interval 0.0 to 50.0	0 score on a scale Interval 0.0 to 65.0
Change (Δ) in Symptoms (Auditory Hallucinations) Change in VAS score (post-pre)	0 score on a scale Interval -44.0 to 1.0	0 score on a scale Interval -9.0 to 48.0	0 score on a scale Interval -9.0 to 50.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Visual Hallucinations) Pre-TBS	0 score on a scale Interval 0.0 to 52.0	0 score on a scale Interval 0.0 to 79.0	0 score on a scale Interval 0.0 to 50.0
Change (Δ) in Symptoms (Visual Hallucinations) Post-TBS	0 score on a scale Interval 0.0 to 53.0	0 score on a scale Interval 0.0 to 56.0	0 score on a scale Interval 0.0 to 50.0
Change (Δ) in Symptoms (Visual Hallucinations) Change in VAS score (post-pre)	0 score on a scale Interval -22.0 to 9.0	0 score on a scale Interval -29.0 to 8.0	0 score on a scale Interval -13.0 to 50.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Paranoid Ideation) Pre-TBS	0 score on a scale Interval 0.0 to 55.0	0 score on a scale Interval 0.0 to 63.0	0 score on a scale Interval 0.0 to 71.0
Change (Δ) in Symptoms (Paranoid Ideation) Post-TBS	0 score on a scale Interval 0.0 to 50.0	0 score on a scale Interval 0.0 to 59.0	0 score on a scale Interval 0.0 to 100.0
Change (Δ) in Symptoms (Paranoid Ideation) Change in VAS score (post-pre)	0 score on a scale Interval -24.0 to 41.0	0 score on a scale Interval -43.0 to 3.0	0 score on a scale Interval -18.0 to 43.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Ideas/Delusions of Reference) Pre-TBS	0 score on a scale Interval 0.0 to 55.0	0 score on a scale Interval 0.0 to 51.0	0 score on a scale Interval 0.0 to 53.0
Change (Δ) in Symptoms (Ideas/Delusions of Reference) Post-TBS	0 score on a scale Interval 0.0 to 50.0	0 score on a scale Interval 0.0 to 54.0	0 score on a scale Interval 0.0 to 53.0
Change (Δ) in Symptoms (Ideas/Delusions of Reference) Change in VAS score (post-pre)	0 score on a scale Interval -5.0 to 22.0	0 score on a scale Interval -50.0 to 3.0	0 score on a scale Interval 0.0 to 11.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Intermittent TBS (iTBS) n=22 Participants Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 Participants Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 Participants Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Change (Δ) in Symptoms (Delusions of Control) Pre-TBS	0 score on a scale Interval 0.0 to 50.0	0 score on a scale Interval 0.0 to 25.0	0 score on a scale Interval 0.0 to 3.0
Change (Δ) in Symptoms (Delusions of Control) Post-TBS	0 score on a scale Interval 0.0 to 29.0	0 score on a scale Interval 0.0 to 73.0	0 score on a scale Interval 0.0 to 11.0
Change (Δ) in Symptoms (Delusions of Control) Change in VAS score (post-pre)	0 score on a scale Interval -48.0 to 28.0	0 score on a scale Interval -24.0 to 48.0	0 score on a scale Interval -2.0 to 11.0

Adverse Events

Intermittent TBS (iTBS)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Continuous TBS (cTBS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TBS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intermittent TBS (iTBS) n=22 participants at risk Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.	Continuous TBS (cTBS) n=21 participants at risk Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.	Sham TBS n=25 participants at risk Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
Injury, poisoning and procedural complications Discomfort from TMS	9.1% 2/22 • Number of events 2 • Varied. Approximately one-month time frame (mean 11.6 ± 6.6, range 4-28 days). Participants were monitored for adverse events from enrollment to end of study participation.	0.00% 0/21 • Varied. Approximately one-month time frame (mean 11.6 ± 6.6, range 4-28 days). Participants were monitored for adverse events from enrollment to end of study participation.	4.0% 1/25 • Number of events 1 • Varied. Approximately one-month time frame (mean 11.6 ± 6.6, range 4-28 days). Participants were monitored for adverse events from enrollment to end of study participation.

Additional Information

Ann Shinn, MD

McLean Hospital

Phone: 617-855-3053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place