CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Excitatory TMS +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02642029
NCT02642029N/ACompleted
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Cerebellar Transcranial Magnetic Stimulation (cTMS) in Psychotic Disorders: Effect on Time Perception, Executive Function, and Mood and Psychotic Symptoms

Mclean Hospital·interventional·Posted Dec 30, 2015·Updated Dec 30, 2022

In Brief

A clinical study evaluating Excitatory TMS, Inhibitory TMS, and 1 other intervention for Schizophrenia and 2 related conditions. Completed, enrolled 28 participants across 2 sites.

Detailed Summary

The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the impact of modulating cerebellar activity on time perception, executive function, and mood and psychotic symptoms in psychosis patients (i.e., schizophrenia, schizoaffective disorder, and bipolar disorder with psychotic features). The investigators hypothesize that abnormally reduced activity in the cerebellum contributes to the abnormalities in patients, that cerebellum-mediated disruptions in time perception may partially underlie executive dysfunction and symptoms, and that cerebellar stimulation will normalize disease-relevant outcome measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Bipolar Disorder I
CountriesUnited States
CollaboratorsMassachusetts General Hospital

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartFeb 18, 2016
Primary CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.5 years ago

Interventions

Excitatory TMSdevice

Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.

Inhibitory TMSdevice

Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.

Sham TMSdevice

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.