Accelerated TMS in Psychosis

NCT05567848 | Suspended Phase 1 FDA Device

• 1 other identifier: 2022P000689
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the tolerability and efficacy of an accelerated schedule of Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder; Prodromal Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Tolerability of accelerated TMS

  Participants will be monitored for routinely surveyed on their experience of side effects of TMS. These include both common effects such as headache or neck pain as well as rarer side effects such as dizziness.

  5 days of multiple session of TMS per day

Secondary Outcomes (4)

• Change in cerebellar-cerebral resting-state functional connectivity

  Before treatment (Baseline) and 1 week and 3 weeks post treatment

• Change in severity of negative symptoms of schizophrenia

  Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment

• Change in auditory hallucination severity

  Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment

• Change in information processing speed

  Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment

Study Arms (1)

repetitive Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation (rTMS) in a iTBS pattern to the cerebellum at 100% of resting motor threshold

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

rTMS is a technique of TMS that allows the selective external manipulation of neural activity in a non-invasive manner. During TMS, a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field that in turn induces electrical current in neurons and allows the modulation of neural circuitry. The combination of TMS with functional MRI allows the selective targeting and modulation of brain networks. The repeated application of rTMS can cause long term changes in behavior and task performance that is reflected in altered brain network connectivity. The pattern of rTMS will consist of intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses per session. Sessions will be separated by an interval of 50 minutes (up to a total of 8 per day).

repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years
• Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder) or have been identified as being at clinical high risk for developing a psychotic disorder.
• Must be able to read, speak and understand English
• Must be judged by study staff to be capable of completing the study procedures
• Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.

You may not qualify if:

• Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
• Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
• Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of multiple seizures or diagnosis of epilepsy
• Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease
• Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)
• Pacemaker
• Implanted medication pump
• Vagal nerve stimulator
• Deep brain stimulator or transcutaneous electric nerve stimulation unit
• Ventriculo-peritoneal shunt
• Signs of increased intracranial pressure
• Intracranial lesion

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizotypal Personality Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Roscoe O Brady, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair for Research, Department of Psychiatry

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 5, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)