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.
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.
Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
History of epilepsy;
Clinical diagnosis of major cognitive disorder (i.e., dementia);
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);
Crossover
Transcranial direct current stimulation (tDCS)
DeviceThe 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.
Sham tDCS
DeviceSham-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.
Percentage of Participants that met Inclusion Criteria
Percentage of participants screened that met Inclusion Criteria
Percentage of Participants that Agreed to Randomization
Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.
Completed period 1 of study
Percentage of participants who completed first 2 weeks of treatment or sham
Completed period 2 of study
Percentage of participants that completed both the first period, the washout period and the second period of the study
Problem Behaviors Assessment Scale (PBA-S)
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.
Frontal Assessment Battery (FAB)
This scale is a brief cognitive and behavioral battery. The total maximum score is 18, with higher scores indicating better performance.
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
Huntington's Disease Society of America
Collaborator
