Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia

March 11, 2024 updated by: Mark A. Halko, PhD, Mclean Hospital

Empirical Validation of a Cerebellar-cortical Hallucination Circuit

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study tests the hypothesis that hallucinations in schizophrenia are mediated by network pathophysiology, and that network pathophysiology can be quantified by the functional connectivity of a cerebellar-thalamo-cortical circuit. To accomplish this, participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who experience auditory hallucinations.

Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of schizophrenia symptom severity. These assessments include reporter-based measures such as the Positive and Negative Syndrome Scale (PANSS).

Participants will then undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.

Participants will then undergo five days of twice daily rTMS sessions.

One week after the last rTMS session, participants will undergo follow-up MRI imaging and the same study assessments.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Recruiting
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

  • substance use disorder in past 3 months
  • ambidexterity
  • contraindications for TMS or MRI including :
  • history of neurological disorder
  • history of head trauma resulting in loss of consciousness
  • history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
  • metal in brain or skull
  • implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt
  • claustrophobic in MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active cerebellum rTMS
Cerebellar targeted iTBS, twice daily, one week.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry.

The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses.

Other Names:
  • iTBS
Sham Comparator: Sham cerebellum rTMS
Cerebellar targeted sham iTBS, twice daily, one week.
Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry.

The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses.

Sham is achieved by using a coil with a magnetic shield preventing magnetic field from reaching the head.

Other Names:
  • iTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional connectivity
Time Frame: baseline, 1 week after TMS
change in functional connectivity of a putative cerebellar-thalamic-cortical hallucination circuit (cerebellum to thalamus) will be assessed before and after (1 week followup) TMS stimulation.
baseline, 1 week after TMS
Positive and Negative Syndrome Scale (PANSS)
Time Frame: baseline
The PANSS is clinical rating scale of symptom severity . Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).
baseline
Scale for the Assessment of Positive Symptoms (SAPS)
Time Frame: baseline
The SAPS is clinical rating scale of symptom severity . Each descriptor is rated on a 5 point scale from 1=(absence of any symptom) to 5=(extremely severe symptoms).
baseline
Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)
Time Frame: baseline
The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

National Institute of Mental Health (NIMH)
Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Mark Halko, PhD, McLean Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P002459
  • R01MH126000 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

deidentified participant data will be shared with NIMH Data Repository (NDA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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