University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Location status: Recruiting
Location contact
Antonio L Teixeira, MD, PhD
CONTACT
Thiago Macedo e Cordeiro, MD, MSc
CONTACT
NCT Number: NCT06843252
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 for follow ups and to undergo additional cognitive tests and questionnaires. Participants will also be asked to answer questionnaires via a web conferencing platform (Zoom) during the course of the study. Caregivers of the participants will be asked to answer questionnaires to collect more information about the participants.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
Location status: Recruiting
Antonio L Teixeira, MD, PhD
CONTACT
Thiago Macedo e Cordeiro, MD, MSc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Caregiver
Exclusion criteria
Caregiver
The active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC.
Other names: tDCS
Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature.
Other names: Control
Time frame: Baseline
Percentage of participants screened that met Inclusion Criteria
Time frame: Baseline
Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.
Time frame: Day 13
Percentage of participants who completed first 2 weeks of treatment or sham
Time frame: Day 35
Percentage of participants that completed both the first period, the washout period and the second period of the study
Time frame: Day 36 (or day 37)
Percentage of participants that completed study from randomization to tDCS/Sham crossed over to alternate treatment/sham and returned for final visit
Time frame: Day 14 and Day 35
This Likert scale scores 10 items for user acceptability. Each item is scored from 0-10 giving. Some items have negative valence, in which lower scores indicate higher acceptability. An averaged of adjusted scores for all items is calculated to produce a global acceptability score ranging from 0 to 10. A higher score on the global score indicates better acceptability.
Time frame: Day 8, 14, 29 and 35
This Likert scale includes 10 items scored from 0-10 for possible side effects. The first 9 items include a list of possible side effects and the last item is free field for the report of any additional side effects. Lower scores indicate less intensity of side effects. Scores will be reported for each individual item.
Time frame: Baseline, and days 14, 22, and 35.
This scale rates the participant's average behavior over the past weeks by taking into account the severity and frequency of a range of psychiatric symptoms. There are 11 items assessed with a possible total score range of 0-176. A lower score indicates less psychiatric symptoms.
Time frame: Baseline, and days 14 and 35.
This scale is a brief cognitive and behavioral battery. The total maximum score is 18, with higher scores indicating better performance.
Contact information is provided by the study sponsor or research team.
Antonio L Teixeira, MD, PhD
CONTACT
Thiago Macedo e Cordeiro, MD, MSc
CONTACT
The University of Texas Health Science Center at San Antonio
Other
Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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