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Device

Transcranial Direct Current Stimulation for Mild Cognitive Impairment (PATH Trial)

Phase 2

Recruiting

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

Age 55 years and older

Active diagnosis of amnestic mild cognitive impairment

Must not have

Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)

Mild traumatic brain injury within past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and immediately after completion of each hd-tdcs condition

Summary

This trial will investigate if previous mild brain trauma is linked to certain biological changes, using high-definition transcranial direct current stimulation and blood-based biomarker tests. People with and without a history of mild brain trauma will be enrolled.

Who is the study for?

This trial is for individuals aged 55 and older with amnestic mild cognitive impairment (aMCI). It's open to all genders and ethnicities, fluent in English. Participants must have a history of mild traumatic brain injury (mTBI) or no such history for the control group. Exclusions include recent mTBI, severe brain injuries, major neurological/cardiovascular conditions, substance use disorders, serious psychiatric issues, sensory impairments affecting testing, or skull/brain implants.

What is being tested?

The study investigates if biological changes in aMCI are linked to past mTBIs using high definition transcranial direct current stimulation (HD-tDCS) alongside blood biomarkers. It includes those with and without an mTBI history to compare results.

What are the potential side effects?

While not explicitly stated here, HD-tDCS can typically cause side effects like slight scalp discomfort at the electrode site during stimulation, itching sensation under the electrodes, fatigue or headache post-stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 years old or older.

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I have been diagnosed with mild memory loss problems.

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I have (or have not) had a mild traumatic brain injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had a major brain condition like a stroke, epilepsy, or brain tumor.

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I had a mild brain injury in the last year.

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I have never had a major heart condition like a heart attack or heart failure.

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I am taking medication that affects brain stimulation treatments.

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I have had a serious brain injury in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and immediately after completion of each hd-tdcs condition

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and immediately after completion of each hd-tdcs condition

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and immediately after completion of each hd-tdcs condition for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Rey Auditory Verbal Learning Test Score

Secondary study objectives

Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test

Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active left temporal HD-tDCSActive Control1 Intervention

Electrodes will be placed in a 4x1 ring configuration over the left temporal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

Group II: Active left frontal HD-tDCSActive Control1 Intervention

Electrodes will be placed in a 4x1 ring configuration over the frontal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

Group III: Sham HD=tDCSPlacebo Group1 Intervention

Electrodes will be placed in the same 4x1 ring configuration over the frontal region as the active left frontal condition to ensure a useful control condition. Stimulation will consist of a 30-second ramp up period until reaching 2 mA, followed immediately by a 30-second ramp down, and off for 29 minutes. The same ramp up and down process will be repeated in the final minute of the session to help preserve masking of conditions. Sham stimulation will be applied back-to-back over three consecutive days.

0 / 8Eligibility criteria met