Trials / Recruiting
RecruitingNCT05446584
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.
Detailed description
Ten study visits will be completed by each participant. The initial visit will include a blood draw and a baseline memory evaluation. Afterwards, participants will be randomized to begin with one of 3 conditions of HD-tDCS. The three conditions are sham-control, active stimulation to frontal region, and active stimulation to left temporal region. All participants will be expected to completed each HD-tDCS condition, which will be counterbalanced and separated by 14 days. Active HD-tDCS will be applied at 2 mA for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. All subjects will complete memory assessments again immediately following each HD-tDCS condition for a total of four test sessions.
Conditions
- Mild Cognitive Impairment
- Amnestic Mild Cognitive Disorder
- Amnestic Mild Cognitive Impairment
- Mild Traumatic Brain Injury
- Concussion, Brain
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High Definition Transcranial Direct Current Stimulation | HD-tDCS for this study is not intended to be a treatment, and will be applied continuously for 30 minutes at sham (0 mA) or 2 mA for active conditions across 3 consecutive daily sessions to probe neural circuit integrity. This specific HD-tDCS device is completely computer driven, running on a laptop using specialized software. Circular electrodes (12-mm in diameter) filled with conductive gel will be placed in a 4x1 ring configuration with the central electrode being the anode surrounded by four cathodes. |
Timeline
- Start date
- 2023-04-20
- Primary completion
- 2027-05-01
- Completion
- 2027-05-31
- First posted
- 2022-07-06
- Last updated
- 2025-05-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05446584. Inclusion in this directory is not an endorsement.