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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PATH Trial 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.Check my eligibility

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.See study design

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.

PATH Trial 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.

PATH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Rey Auditory Verbal Learning Test Score

Secondary outcome measures

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

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

PATH 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 left 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 left 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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,724 Total Patients Enrolled

Media Library

High Definition Transcranial Direct Current Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05446584 — Phase 2

Mild Cognitive Impairment Research Study Groups: Active left temporal HD-tDCS, Sham HD=tDCS, Active left frontal HD-tDCS

Mild Cognitive Impairment Clinical Trial 2023: High Definition Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT05446584 — Phase 2

High Definition Transcranial Direct Current Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05446584 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Active left frontal HD-tDCS received endorsement from the FDA?

"Though no efficacy data has been collected, there is some clinical evidence to suggest that Active left frontal HD-tdcs can be safe for patients. Therefore, it was rated a 2 on our internal scale of 1 to 3."

Answered by AI

Is there availability to join this research initiative?

"Contrary to the information provided on clinicaltrials.gov, this medical trial is no longer actively seeking candidates as of July 5th 2022 - which was its last update date since being posted on January 1st 2023. However, there are 1490 other trials currently recruiting participants across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Christian Lobue 2023. "Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05446584.

All > Memory > Traumatic Brain Injury