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Behavioural Intervention

Brain Stimulation for Depression

N/A
Recruiting
Led By Krystal L Parker, Ph.D
Research Sponsored by Krystal Parker, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of recurrent seizures or epilepsy
Atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Awards & highlights

Summary

This trial will test whether electrical brain stimulation can help improve cognition and mood in patients with various mental disorders.

Who is the study for?
This trial is for individuals with schizophrenia, autism, bipolar disorder, Parkinson's disease, or major depression. Participants must be able to consent and not have a recent substance use disorder (except tobacco), uncontrolled high blood pressure, significant heart disease, kidney disease, seizures/epilepsy or certain other medical conditions.Check my eligibility
What is being tested?
The study tests if cerebellar stimulation using Repetitive Transcranial Magnetic Stimulation (rTMS) can improve cognitive function and mood in patients. Some will receive real rTMS while others get a sham treatment to compare outcomes.See study design
What are the potential side effects?
Possible side effects of rTMS include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles. Rarely it may cause seizures or hearing loss if ear protection isn't used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures or epilepsy.
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I have atrial fibrillation.
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I have a serious heart condition.
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My blood pressure and heart rate are stable.
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My high blood pressure is not under control.
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I have kidney disease.
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I am unable to give consent for the study myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in disease-specific symptom rating scale, one scale identified for each group (MADRS for bipolar group; PANSS for schizophrenia group; UPDRS in Parkinson's patient group).
Secondary outcome measures
Bipolar group: Change in Columbia Suicide Severity Rating Scale.
Bipolar group: Change in Young Mania Rating Scale.
Change in CGI.
+12 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: patient active rTMSExperimental Treatment1 Intervention
Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum.
Group II: Control active rTMSActive Control1 Intervention
Group III: Control sham rTMSPlacebo Group1 Intervention
Group IV: patient sham rTMSPlacebo Group1 Intervention
Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Krystal Parker, PhDLead Sponsor
Krystal L Parker, Ph.DPrincipal InvestigatorUniveristy of Iowa
~0 spots leftby Aug 2024