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TMS for Schizophrenia Hallucinations

N/A
Recruiting
Led By Mark Halko, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of schizophrenia or schizoaffective disorder
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline

Summary

This trial will use transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia and whether or not the magnetic field can improve symptoms.

Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder. It's not suitable for those who've had substance use disorders recently, have ambidexterity, contraindications to TMS or MRI like neurological issues, head trauma with unconsciousness, seizures/epilepsy (or family history of it), metal in the brain/skull, implanted medical devices, or claustrophobia in MRI.
What is being tested?
The study tests transcranial magnetic stimulation (TMS) as a noninvasive brain stimulation technique to understand and potentially improve hallucinations in schizophrenia. Participants will receive repetitive TMS (rTMS) or a sham version that mimics the procedure without actual stimulation.
What are the potential side effects?
Possible side effects of rTMS include discomfort at the coil placement site on the scalp, headache, lightheadedness, and rare risk of seizure. The sham treatment may cause similar sensations due to placebo effect but does not involve active brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have a neurological disorder, head trauma, seizures, epilepsy, metal in my head, implanted devices, or claustrophobia in MRI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)
Positive and Negative Syndrome Scale (PANSS)
Scale for the Assessment of Positive Symptoms (SAPS)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active cerebellum rTMSActive Control1 Intervention
Cerebellar targeted iTBS, twice daily, one week.
Group II: Sham cerebellum rTMSPlacebo Group1 Intervention
Cerebellar targeted sham iTBS, twice daily, one week.

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,805 Total Patients Enrolled
19 Trials studying Schizophrenia
1,354 Patients Enrolled for Schizophrenia
Beth Israel Deaconess Medical CenterOTHER
860 Previous Clinical Trials
12,932,438 Total Patients Enrolled
22 Trials studying Schizophrenia
2,203 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,931 Previous Clinical Trials
2,744,966 Total Patients Enrolled
254 Trials studying Schizophrenia
89,963 Patients Enrolled for Schizophrenia
Mark Halko, PhDPrincipal InvestigatorMclean Hospital

Media Library

Active cerebellum rTMS Clinical Trial Eligibility Overview. Trial Name: NCT05343598 — N/A
Schizophrenia Research Study Groups: Active cerebellum rTMS, Sham cerebellum rTMS
Schizophrenia Clinical Trial 2023: Active cerebellum rTMS Highlights & Side Effects. Trial Name: NCT05343598 — N/A
Active cerebellum rTMS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343598 — N/A
~25 spots leftby Oct 2026
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