Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Participants will be asked to participate in this research study of a device that creates transcranial direct current stimulation (tDCS). The researchers hope to learn if 30 minute sessions of transcranial direct current stimulation (tDCS) improve such a mood or feelings in people with Alzheimer's Disease. This study involves the use of an investigational device called a tDC stimulator. Investigational means that the device has not yet been approved by the U.S. Food \& Drug Administration (FDA) for treating Alzheimer's Disease. This study will help find out what effects, good and/or bad, this has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• individuals aged 18-85 years with confirmed HD mutation and/or established family history alongside typical symptoms (i.e., chorea) of HD;

• early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn criteria, also known as the UHDRS total functional capacity (TFC) scale (Bates, Tabrizi, and Jones 2014);

• exhibit mild to moderate behavioral symptoms defined by severity scores in the PBA-S between 1 and 3 for any of the evaluated symptoms and no symptoms with a severity score of 4;

• stable doses of medications for at least one month.

• Ability of subject to understand and the willingness to sign a written informed consent document.

• Have a caregiver willing to be present during tDCS sessions and answer questionnaires.

⁃ Caregiver

• An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.

• Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.

• Adequate reading, writing, hearing, and verbal capacity to provide collateral information about the study participant as well as answer questions related to their health and care.

Locations
United States
Texas
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Thiago Macedo e Cordeiro, MD, MSc
macedoecorde@uthscsa.edu
210-450-8418
Backup
Antonio L Teixeira, MD, PhD
teixeiraa@uthscsa.edu
210-450-8636
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 24
Treatments
Experimental: Active TDCS treatment
The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation.
Sham_comparator: Sham TDCS treatment
Sham-tDCS treatment will consist of the same montage but the electric current will be applied only in the first and final 30s of stimulation.
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov