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Behavioural Intervention
tDCS for Traumatic Brain Injury
Phase 2
Waitlist Available
Led By Tasha M Nienow, PhD
Research Sponsored by Minneapolis Veterans Affairs 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 post-intervention, 8-9 weeks after baseline assessment
Summary
This trial aims to assess the effects of tDCS on patients with mild traumatic brain injury, identify biomarkers of treatment response, and measure acceptability/tolerability of the approach. EEGs will be used to measure neural efficiency before/after.
Who is the study for?
This trial is for veterans aged 18-65 who have had a mild traumatic brain injury over a year ago and are enrolled at the Minneapolis VA Health Care System. It's not for those with psychotic disorders, recent substance use issues, severe depression, other cognitive impairments, or medical conditions that don't allow TDCS.
What is being tested?
The study tests if transcranial direct current stimulation (TDCS) can improve cognition in patients with mild traumatic brain injury. Participants will be randomly assigned to receive either real TDCS or sham stimulation alongside working memory training.
What are the potential side effects?
Possible side effects of TDCS may include discomfort at the electrode site, itching or tingling during stimulation, headache, fatigue, nausea or dizziness. However, it's generally considered safe with minimal adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-intervention, 8-9 weeks after baseline assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention, 8-9 weeks after baseline assessment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Wechsler Adult Intelligence Scale (WAIS)-III Working Memory Index
Secondary study objectives
University of California Performance Based Skills Assessment
Other study objectives
Resting state electroencephalogram (EEG)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial Direct Current StimulationExperimental Treatment1 Intervention
Participants will receive 24 sessions (3 times a week) of anodal transcranial direct current stimulation concurrent with working memory training. Stimulation will be administered at 2 milliamps (mA) for 20 minutes over the left dorsal lateral prefrontal cortex.
Group II: ShamPlacebo Group1 Intervention
Participants will receive 24 sessions of working memory training. The experience of transcranial direct current stimulation will be simulated by administering 30 seconds of stimulation at the beginning of the session.
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Who is running the clinical trial?
Minnesota Veterans Medical Research and Education FoundationOTHER
3 Previous Clinical Trials
131 Total Patients Enrolled
State of MinnesotaUNKNOWN
Minneapolis Veterans Affairs Medical CenterLead Sponsor
76 Previous Clinical Trials
354,744 Total Patients Enrolled
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