RECRUITING

Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms

Conditions

Alzheimer Disease Transcranial direct current stimulation TDCS Home-based Cognitive symptoms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-15

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06801639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. individuals aged 18-85 years with confirmed HD mutation and/or established family history alongside typical symptoms (i.e., chorea) of HD; 2. 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); 3. 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; 4. stable doses of medications for at least one month. 5. Ability of subject to understand and the willingness to sign a written informed consent document. 6. Have a caregiver willing to be present during tDCS sessions and answer questionnaires. 1. An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician. 2. Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study. 3. 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.	1. Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.); 2. History of epilepsy; 3. Clinical diagnosis of major cognitive disorder (i.e., dementia); 4. Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011); 5. Being an active participant in other therapeutic clinical trial; 6. Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent. 7. Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.

Inclusion Criteria

Exclusion Criteria

1. individuals aged 18-85 years with confirmed HD mutation and/or established family history alongside typical symptoms (i.e., chorea) of HD;
2. 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);
3. 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;
4. stable doses of medications for at least one month.
5. Ability of subject to understand and the willingness to sign a written informed consent document.
6. Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
1. An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
2. Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
3. 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.

1. Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
2. History of epilepsy;
3. Clinical diagnosis of major cognitive disorder (i.e., dementia);
4. Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011);
5. Being an active participant in other therapeutic clinical trial;
6. Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent.
7. Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.

Contacts and Locations

Study Contact

Thiago Macedo e Cordeiro, MD, MSc

CONTACT

210-450-8418

macedoecorde@uthscsa.edu

Antonio L Teixeira, MD, PhD

CONTACT

210-450-8636

teixeiraa@uthscsa.edu

Principal Investigator

Thiago Macedo e Cordeiro, MD, MSc

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Thiago Macedo e Cordeiro, MD, MSc, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15

Study Completion Date2028-12

Study Record Updates

Study Start Date2025-07-15

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Transcranial direct current stimulation
TDCS
Home-based
Cognitive symptoms

Additional Relevant MeSH Terms

Alzheimer Disease