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Noninvasive Brain Stimulation

Noninvasive Brain Stimulation for Mild Cognitive Impairment

N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Native English speakers
Age 50 and older
Must not have
Lifetime history of epilepsy
Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately following last hd-tdcs session, and again at 3-month follow-up

Summary

This trial will test if a certain kind of brain stimulation can improve memory in people with a history of brain injury.

Who is the study for?
This trial is for individuals aged 50 or older, who are native English speakers with at least a high school education. Participants must have mild cognitive impairment due to past traumatic brain injury (TBI), but not within the last two years. They can't join if they've had major cardiovascular events, epilepsy, severe psychiatric disorders, substance use disorder, metal in the head, or take certain medications.
What is being tested?
The study tests whether ten sessions of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on a specific brain area improve memory in people with cognitive issues from past TBI. Memory will be checked after treatment and three months later.
What are the potential side effects?
While HD-tDCS is generally considered safe, potential side effects may include slight scalp discomfort during stimulation, itching or tingling sensations under the electrodes, headache or fatigue post-session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a native English speaker.
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I am 50 years old or older.
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I have been diagnosed with mild cognitive impairment.
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I have a history of traumatic brain injury as defined by VA/DOD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had epilepsy at some point in my life.
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I am not taking any medication that could interfere with the study treatment.
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I have had a stroke, heart attack, or heart failure in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately following last hd-tdcs session, and again at 3-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately following last hd-tdcs session, and again at 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Memory

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active HD-tDCSActive Control1 Intervention
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Group II: Sham HD-tDCSPlacebo Group1 Intervention
Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,659 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
291 Previous Clinical Trials
246,154 Total Patients Enrolled

Media Library

High Definition Transcranial Direct Current Stimulation (Noninvasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04504630 — N/A
Mild Cognitive Impairment Research Study Groups: Active HD-tDCS, Sham HD-tDCS
Mild Cognitive Impairment Clinical Trial 2023: High Definition Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT04504630 — N/A
High Definition Transcranial Direct Current Stimulation (Noninvasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504630 — N/A
~0 spots leftby Dec 2024