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Accelerated TMS for Schizophrenia (ATP Trial)
Phase 1 & 2
Waitlist Available
Led By Roscoe O Brady, MD, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before treatment (baseline) and 1 week and 3 weeks and 24 weeks post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is to test if a more intense Transcranial Magnetic Stimulation schedule can effectively treat symptoms of psychotic disorders like schizophrenia.
Who is the study for?
This trial is for adults aged 18-65 with a diagnosis of schizophrenia, schizoaffective disorder, or at high risk for psychosis. Participants must be stable outpatients, fluent in English, and capable of completing study procedures without recent hospitalizations or medication changes.
What is being tested?
The trial tests the safety and effectiveness of an accelerated schedule of repetitive Transcranial Magnetic Stimulation (rTMS) to treat symptoms associated with psychotic disorders like schizophrenia.
What are the potential side effects?
Possible side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures in rare cases, and hearing issues if ear protection isn't used during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before treatment (baseline) and 1 week and 3 weeks and 24 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before treatment (baseline) and 1 week and 3 weeks and 24 weeks post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tolerability of accelerated TMS
Secondary study objectives
Change in auditory hallucination severity
Change in cerebellar-cerebral resting-state functional connectivity
Change in information processing speed
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention
repetitive Transcranial Magnetic Stimulation (rTMS) in a iTBS pattern to the cerebellum at 100% of resting motor threshold
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive Transcranial Magnetic Stimulation (rTMS)
2014
N/A
~510
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,941 Total Patients Enrolled
22 Trials studying Schizophrenia
2,251 Patients Enrolled for Schizophrenia
Roscoe O Brady, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have conditions that increase risks from rTMS or MRI.I have had a head injury that caused me to lose consciousness for a long time or left me with lasting neurological issues.I have had fainting spells that might be seizures.I have a chronic condition that could lead to a medical emergency if I have a seizure.I have had many seizures or have been diagnosed with epilepsy.I do not have a progressive neurological disorder like MS or Parkinson's.I am able to complete all study-related procedures.I have been diagnosed with schizophrenia or schizoaffective disorder, or I am at high risk for developing a psychotic disorder.I do not have signs of increased pressure in my brain or brain lesions.I am between 18 and 65 years old.I have a known brain disorder, cerebral palsy, had a severe head injury, or significant physical brain abnormalities.My medications and medical history will be reviewed by the study leader.I haven't been hospitalized or changed my medications in the last 30 days.I have been diagnosed with schizophrenia, schizoaffective disorder, or am at high risk for a psychotic disorder.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Research Study Groups:
This trial has the following groups:- Group 1: repetitive Transcranial Magnetic Stimulation (rTMS)
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