Noninvasive Brain Stimulation for Mild Cognitive Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Amphetamines, L-dopa, others

Disqualifiers: Stroke, Epilepsy, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

26 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Active HD-tDCS Active Control 1 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-tDCS Placebo Group 1 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.

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

Approved in United States as HD-tDCS for:

• Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement

Approved in European Union as HD-tDCS for:

• Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement

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+