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Brain Stimulation for Addiction and Mental Health Issues
N/A
Waitlist Available
Research Sponsored by Virginia Polytechnic Institute and State University
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 outcome measured throughout study participation - an average of 4 weeks per participant.
Awards & highlights
Summary
This trial looks at the effects of different brain stimulation settings on muscle contractions in order to better understand how they could be used to help with addiction, pain, and mental health issues.
Who is the study for?
This trial is for individuals who speak English and are interested in participating in a study examining brain stimulation's effects on muscle contractions. They must not have had a significant head injury, substance dependence, claustrophobia, active medical disorders affecting the brain, neurological disorders, certain implants or be pregnant.Check my eligibility
What is being tested?
The study tests how different settings of Low-intensity Focused Ultrasound (LIFU) affect muscle contractions. It involves structural imaging with fMRI and CT to align LIFU and TMS devices for temporary changes in brain activity. Muscle responses are recorded using EMG.See study design
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound device, headache or dizziness during or after stimulation sessions, skin irritation at the site of electrode placement for EMG recording.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measured throughout study participation - an average of 4 weeks per participant.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measured throughout study participation - an average of 4 weeks per participant.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Waveforms
Trial Design
1Treatment groups
Experimental Treatment
Group I: Parameter TrialsExperimental Treatment1 Intervention
Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-intensity Focused Ultrasound
2022
N/A
~30
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
146 Previous Clinical Trials
28,430 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a head injury that caused you to lose consciousness for more than 10 minutes in the past.You are pregnant.You have a history of being addicted to alcohol or drugs.You cannot undergo MRI, CT, or TMS scans due to certain medical conditions.You have a fear of enclosed spaces.You currently have a medical condition or are receiving treatment that may affect your brain.You have a history of neurological disorder.You have a pacemaker, metal implants, or other devices that cannot be safely scanned during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Parameter Trials
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.
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