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Device
tDCS for Huntington's Disease
N/A
Recruiting
Led By Erin Stimming, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
Confirmed HD mutation carriers
Must not have
Clinical diagnosis of major cognitive disorder or dementia
History of epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4, week 8
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a non-invasive brain stimulation called tDCS is safe and effective for treating symptoms in early to middle stage Huntington's disease patients.
Who is the study for?
This trial is for individuals with Huntington's Disease in early to middle stages who show mild to moderate behavioral symptoms like apathy, irritability, or depression. They must have stable medication doses for a month and no major cognitive disorders, unstable medical conditions, brain metal objects, or high suicide risk.
What is being tested?
The study tests the safety and effectiveness of home-based transcranial direct current stimulation (tDCS) on behavioral and cognitive symptoms associated with Huntington's Disease. It aims to see if tDCS can improve these symptoms when administered at home.
What are the potential side effects?
While not explicitly listed here, potential side effects of tDCS may include discomfort at the electrode site, itching or tingling during stimulation, headache, fatigue or nausea. Serious side effects are rare but could involve seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is in the early or moderate stages.
Select...
I carry the HD mutation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a major cognitive disorder or dementia.
Select...
I have a history of epilepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 4, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire
Secondary study objectives
Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: active tDCSExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tDCS
2018
N/A
~790
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,847 Total Patients Enrolled
Erin Stimming, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Antonio L Teixeira Jr, MD,PhD,MScPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience symptoms like apathy, irritability, anxiety, depression, aggression, or repetition.My condition is in the early or moderate stages.I carry the HD mutation.My medication doses have been the same for at least a month.You have a risk of thinking about or doing things to harm yourself.I have been diagnosed with a major cognitive disorder or dementia.You have metal objects in your brain.I have a history of epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: active tDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.