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

NCT02642029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-12-30

Study results available
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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.

Conditions

Interventions

DEVICE

Excitatory TMS

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

DEVICE

Inhibitory TMS

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

DEVICE

Sham TMS

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Ann K Shinn, MD, MPH · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-18
Primary Completion
2019-06-14
Completion
2019-06-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642029 on ClinicalTrials.gov