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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05343598
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : August 11, 2022
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mark A. Halko, PhD, Mclean Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizo Affective Disorder Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status. Blinding codes are used to determine which side of an active/passive Magpro coil (cool B65 A/P, Magventure A/S, Denmark) is used for stimulation.
Primary Purpose: Basic Science
Official Title: Empirical Validation of a Cerebellar-cortical Hallucination Circuit
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : October 31, 2026
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: iTBS




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. Auditory Hallucination Rating Scale (AHRS) Scale (AHRS) [ Time Frame: baseline ]
    The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05343598


Contacts
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Contact: Mark Halko, PhD mhalko@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Beth Israel Deaconess Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Mark Halko, PhD Mclean Hospital
Publications:

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Responsible Party: Mark A. Halko, PhD, Assistant Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT05343598    
Other Study ID Numbers: 2021P002459
R01MH126000 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: deidentified participant data will be shared with NIMH Data Repository (NDA).

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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
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases