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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with amnestic mild cognitive impairment (aMCI), a condition affecting memory, particularly in those with a history of traumatic brain injury (TBI). The technique, High Definition Transcranial Direct Current Stimulation (HD-tDCS), involves gentle electrical stimulation to the brain to determine its potential to improve memory. Participants will receive either the active treatment or a sham (placebo) version for comparison. Suitable candidates have a current aMCI diagnosis, a history of TBI, and experience memory problems. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatments for memory issues.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that could interact with the treatment, like amphetamines or L-dopa. It's best to discuss your current medications with the trial team to see if any changes are needed.

What prior data suggests that this method is safe for patients with mild cognitive impairment?

Research has shown that High Definition Transcranial Direct Current Stimulation (HD-tDCS) is generally safe for people. In past studies, most participants felt little to no sensation during the sessions, whether they received the actual treatment or a placebo.

One study found that HD-tDCS was well-tolerated by individuals with mild memory problems, with most experiencing no serious issues or discomfort.

Overall, evidence suggests that HD-tDCS is safe for humans, with only mild side effects, if any. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High Definition Transcranial Direct Current Stimulation (HD-tDCS) for mild cognitive impairment because it offers a noninvasive way to potentially enhance brain function. Unlike current treatments that often rely on medications, HD-tDCS uses a mild electrical current to stimulate specific brain regions, aiming to improve memory and cognitive abilities. This method targets the dorsal anterior cingulate region, which plays a crucial role in cognitive processes. The promise of HD-tDCS lies in its ability to deliver targeted brain stimulation without the side effects associated with drugs, making it an innovative approach in cognitive health.

What evidence suggests that high definition transcranial direct current stimulation is effective for improving episodic memory in mild cognitive impairment?

In this trial, participants will receive either active high-definition transcranial direct current stimulation (HD-tDCS) or sham HD-tDCS. Research has shown that HD-tDCS can assist individuals with mild cognitive impairment, often characterized by memory problems. Studies have found that HD-tDCS might enhance thinking skills by delivering a small electrical current to the brain, targeting the area involved in memory and attention. Specifically, one study noted improved learning and memory after several HD-tDCS sessions. Participants reported enhanced memory immediately after the treatment and even weeks later. These findings suggest that HD-tDCS could be promising for boosting memory in individuals with mild cognitive issues and a history of traumatic brain injury. ^{1 6 7 8 9}

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.

I am 50 years old or older.

I have been diagnosed with mild cognitive impairment.

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 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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40984052/

A randomized, triple-blind, sham-controlled trial Effectiveness and safety of high-definition transcranial direct current stimulation in patients with mild cognitive impairment: A randomized, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10745513/

The Effects of Transcranial Direct Current Stimulation in ... Numerous studies have shown that tDCS can have several useful effects in patients with MCI. It is believed to enhance cognitive functions, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006150

High definition transcranial direct current stimulation as an ... Cognitive outcomes were measured at baseline, after the last HD-tDCS session, and 8-weeks post-treatment. The primary outcome was change in total learning ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04599764

High Definition Transcranial Direct Current Stimulation (HD ... Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia; CDR score ≤ 2; Subject under treatment by IAChE for at ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/256998

High Definition Transcranial Direct Current Stimulation (HD ... This program and training model have been demonstrated to be effective and beneficial in patients with vascular cognitive impairment. In the CCT ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/13872877251376547

A randomized, triple-blind, sham-controlled trial HD-tDCS did not enhance global cognition in MCI patients overall. Preliminary findings demonstrated a potential language benefit was observed in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23019010

Tolerability and blinding of high-definition transcranial ... HD-tDCS was well tolerated with mostly no (“none”) or “mild” sensations reported across sessions, regardless of active or sham condition and in both stimulation ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05270408

Noninvasive Brain Stimulation in Mild Cognitive ... The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1356073/full

Safety and feasibility of optimized transcranial direct ... This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...