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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2, week 4, week 8

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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My condition is in the early or moderate stages.

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I carry the HD mutation.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,950 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

active tDCS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05326451 — N/A

Huntington's Disease Research Study Groups: active tDCS

Huntington's Disease Clinical Trial 2023: active tDCS Highlights & Side Effects. Trial Name: NCT05326451 — N/A

active tDCS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05326451 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor accepting individuals aged 55 and older as participants?

"To be eligible for this trial, individuals must fall between the ages of 18 to 70. For those under 18 and over 65, there are 3 separate clinical trials available respectively."

Answered by AI

What goals is this research attempting to accomplish?

"This medical trial aims to measure the number of participants who completed the protocol over a period spanning from baseline to week 8. Secondary objectives include evaluating changes in apathy using Brief Dimensional Apathy Scale (bDAS), which is scored on 9 questions with 0(almost always) being the lowest and 3(hardly ever) denoting higher apathy, gauging anxiety and depression symptoms through Hospital Anxiety and Depression Scale (HADS)'s fourteen-item scale ranging from 0-3, while motor function will be quantified by Unified Huntington disease Rating Scale (UHDRS) consisting of 31 items with ordinal score varying between 0"

Answered by AI

Are there any available slots for individuals to take part in this research?

"According to the most recent version on clinicaltrials.gov, recruitment for this trial has been halted as of April 5th 2022. Its initial posting was dated April 15th 2022 and there are currently 46 other studies with open enrolment at this time."

Answered by AI

Who are the eligible participants for this clinical trial?

"This clinical trial is recruiting 10 individuals that have been diagnosed with Huntington disease and are between the ages of 18 to 70. In addition, participants must be confirmed HD mutation carriers in either early (1-2) or moderate stage 3 according to Shoulson-Fahn criteria. Furthermore, mild to moderate behavioral symptoms such as apathy, irritability, anxiety, depression, aggression and repetition must already exist; also these patients should not change their medication dosages within a month leading up this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Erin Furr Stimming 2023. "Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05326451.

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