Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to assess feasibility, acceptability, and safety of providing transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

confirmed HD mutation carriers 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

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

Disqualifiers

unstable medical conditions

history of epilepsy

metallic objects in the brain

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

Trial design

Design model

Single group

Treatments tested in this trial

  • active tDCS

    Device

    Participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with HD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Sessions will be remotely supervised by trained research staff (RA), and will run from Monday through Friday for four consecutive weeks.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: active tDCSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility as assessed by the number of participants included and who successfully completed the protocol

Time frame
through study completion, an average of 8 weeks
2

Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire

Acceptability will be evaluated using a Likert scale (from 0 \[strongly disagree\] to 10 \[strongly agree\]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.

Time frame
Baseline, week 2, week 4, week 8
3

Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire

Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.

Time frame
week 2, week 4

Secondary outcomes

1

Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

The motor section of the UHDRS consists of 31 items rated on a 5-point ordinal scale ranging from 0 to 4, with a score of 0 indicating no abnormalities and 4 indicating the most severe impairment. Total score range is 0 to 124, with a higher score indicating decreased inability to perform motor tasks.

Time frame
Baseline,week4
2

Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

The cognitive function section of the UHDRS consists of 5 items rated on a 5-point ordinal scale ranging from 0- to 4, with a total score range of 0 to 20 and with a higher score indicating better cognitive performance.

Time frame
Baseline,week4
3

Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)

The behavioral section of the UHDRS consists of 11 items evaluating various behavioral signs and symptoms. Individuals are ranked on both severity and frequency on a 0 to 4 scale, with 0 being not present and 4 being severe and frequent. Total behavioral scores are calculated by summing the severity and frequency items, with a total score range of 0 (no behavioral symptoms) to 88 (most severe behavioral symptoms).

Time frame
Baseline,week4
4

Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)

This scale consists of 9 questions, each scored from 0 (almost always) to 3 (hardly ever), with a total score range of 0 to 27 and a higher score indicating more apathy.

Time frame
Baseline, week 2, week 4, week 8

Other outcomes

Sponsors and contacts

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