26 Participants Needed

Noninvasive Brain Stimulation for Mild Cognitive Impairment

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a native English speaker.
12 years of education or higher
I am 50 years old or older.
See 2 more

Exclusion Criteria

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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 sessions of HD-tDCS or sham stimulation targeting the dorsal anterior cingulate region over 2 weeks

2 weeks
10 visits (in-person)

Immediate Follow-up

Episodic memory tasks are completed immediately following the last HD-tDCS session

1 day

3-Month Follow-up

Participants are monitored for episodic memory improvements and other cognitive measures

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • High Definition Transcranial Direct Current Stimulation
  • Sham HD-tDCS
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Active HD-tDCSActive Control1 Intervention
Group II: Sham HD-tDCSPlacebo Group1 Intervention

High Definition Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

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Approved in United States as HD-tDCS for:
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Approved in European Union as HD-tDCS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials
296
Recruited
249,000+
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