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Brain Stimulation for PTSD
N/A
Recruiting
Led By Gopalkumar Rakesh, PhD
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability and willingness to perform procedures
Meet diagnostic criteria for past-month probable IPV-related PTSD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Summary
This trial will study if a brain stimulation treatment (tDCS) can help adult women with a history of trauma and PTSD.
Who is the study for?
This trial is for adult female students aged 18-55 at a large southern university who have experienced intimate partner violence (IPV) and likely have PTSD. They must be able to give informed consent, perform required tasks, and either not be on medication or on stable medication for at least four weeks.
What is being tested?
The study tests the effects of tDCS—a non-invasive brain stimulation technique—on inhibitory control in participants with probable PTSD from IPV. Participants will do tasks before and after receiving either real or sham tDCS, with their performance compared to see if there's any improvement.
What are the potential side effects?
tDCS is generally considered safe but can cause mild side effects such as itching, tingling, or discomfort at the electrode site. Headache and fatigue may also occur after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to follow through with required medical procedures.
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I have PTSD related to past intimate partner violence.
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I am female.
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I am between 18 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heart Rate (HR)
Skin conductance level (SCL)
Stop Signal Reaction Time (SSRT)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active tDCSActive Control1 Intervention
Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period and a constant current will be delivered for the 15-minutes between ramping
Group II: Shame tDCSPlacebo Group1 Intervention
Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period during which no stimulation will be delivered.
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Who is running the clinical trial?
University of KentuckyLead Sponsor
192 Previous Clinical Trials
223,522 Total Patients Enrolled
Gopalkumar RakeshLead Sponsor
4 Previous Clinical Trials
45 Total Patients Enrolled
Gopalkumar Rakesh, PhDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
8 Total Patients Enrolled
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