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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately following last hd-tdcs session, and again at 3-month follow-up
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately following last hd-tdcs session, and again at 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately following last hd-tdcs session, and again at 3-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,775 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,135 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a native English speaker.You have a significant mental illness like bipolar disorder or schizophrenia.You have a problem with using drugs or alcohol.I have had epilepsy at some point in my life.You have metal pieces in your head.I am not taking any medication that could interfere with the study treatment.I have had a traumatic brain injury in the last 2 years.I have had a stroke, heart attack, or heart failure in the past.I am 50 years old or older.I have been diagnosed with mild cognitive impairment.I have a history of traumatic brain injury as defined by VA/DOD.
Research Study Groups:
This trial has the following groups:- Group 1: Active HD-tDCS
- Group 2: Sham HD-tDCS
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper threshold of participants in this trial?
"Affirmative. Per the details listed on clinicaltrials.gov, this medical research venture is actively seeking participants. The trial was initially posted on December 5th 2020 and the most recent update occured 13 days ago in 2021. 24 individuals must be enrolled from a single site to fulfill its requirements."
Answered by AI
Are there vacancies for enrollees in this clinical trial?
"As per the clinicaltrials.gov entry, recruitment for this medical trial is ongoing and started on December 5th 2020. The page was last modified on December 13th 2021."
Answered by AI
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