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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)
Positive and Negative Syndrome Scale (PANSS)
Scale for the Assessment of Positive Symptoms (SAPS)
+1 moreTrial 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.
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Who is running the clinical trial?
Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,678 Total Patients Enrolled
19 Trials studying Schizophrenia
1,354 Patients Enrolled for Schizophrenia
Beth Israel Deaconess Medical CenterOTHER
839 Previous Clinical Trials
13,010,358 Total Patients Enrolled
21 Trials studying Schizophrenia
1,934 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,801 Previous Clinical Trials
2,661,502 Total Patients Enrolled
250 Trials studying Schizophrenia
89,393 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a neurological disorder, head trauma, seizures, epilepsy, metal in my head, implanted devices, or claustrophobia in MRI.You have had a problem with drugs or alcohol in the past 3 months.Being able to use both hands equally well.I have been diagnosed with schizophrenia or schizoaffective disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Active cerebellum rTMS
- Group 2: Sham cerebellum rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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