Clinical trial NCT06843252: Home-based TDCS (Transcranial Direct Current Stimulation) for Cognitive and Behavioral Symptoms in Huntington's Disease
Official title: Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Huntington Disease
Keywords: Transcranial direct current stimulation
TDCS
Home-based
Cognitive symptoms
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Huntingtons Disease Society of America (HDSA)
First posted: 2025-02-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized double-blind cross-over clinical trial. Participants will be their own control and in addition, caregivers will provide collateral information regarding the participant via structured interviews or questionnaires.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center more time for follow ups and to undergo additional thinking tests and questionnaires. Participants will also be asked to answer questionnaires over the phone or via a web conferencing platform (Zoom) 3 times during the course of the study. Caregivers of the participants will be asked to complete questionnaires to collect more information about the participants.

Detailed description: This clinical trial will investigate the effects of transcranial direct current stimulation (tDCS) over cognitive and behavioral symptoms of patients with Huntington's disease (HD). The study will also investigate underlying neurobiological mechanisms of tDCS in HD with functional and structural neuroimaging techniques.

Eligibility criteria: Inclusion 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.

Caregiver

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.

Exclusion Criteria:

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.

Caregiver

1. Any individual who does not meet all the inclusion criteria

Primary outcomes:
measure: Percentage of Participants that met Inclusion Criteria
timeFrame: Baseline
measure: Percentage of Participants that Agreed to Randomization
timeFrame: Baseline
measure: Completed period 1 of study
timeFrame: Day 13
measure: Completed period 2 of study
timeFrame: Day 35
measure: Completion of study to last visit
timeFrame: Day 36 (or day 37)
measure: TDCS Acceptability Scale
timeFrame: Day 14 and Day 35
measure: tDCS Side Effects Scale
timeFrame: Day 8, 14, 29 and 35
Secondary outcomes:
measure: Problem Behaviors Assessment Scale (PBA-S)
timeFrame: Baseline, and days 14, 22, and 35.
measure: Frontal Assessment Battery (FAB)
timeFrame: Baseline, and days 14 and 35.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Thiago Macedo e Cordeiro, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: