Transcranial Direct Current Stimulation for Huntington's Disease

Overseen By Antonio L Teixeira, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Unstable conditions, Epilepsy, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests transcranial direct current stimulation (tDCS) to determine its effectiveness in improving behavioral symptoms in people with Huntington's Disease. Participants will use a device at home to deliver a gentle electrical current to their brain for 30 minutes daily. The trial compares an active treatment with a sham (fake) treatment to assess effectiveness. It suits those with mild to moderate Huntington's symptoms, confirmed by a family history or genetic test, and who have a caregiver to assist during sessions. As an unphased trial, this study offers participants the chance to contribute to early research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their medications for at least one month, so you won't need to stop taking your current medications if they are stable.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for Huntington's Disease?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In one study involving individuals with Huntington's Disease, participants tolerated tDCS well and did not report major safety concerns.

Another study found that applying tDCS to the front part of the brain was well-tolerated and improved memory compared to a sham (inactive) treatment. These findings suggest that tDCS is a safe option for individuals with Huntington's Disease considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Direct Current Stimulation (tDCS) for Huntington's Disease because it offers a non-invasive way to potentially manage symptoms. Unlike traditional treatments, which often focus on medications that alter neurotransmitter levels, tDCS uses a gentle electrical current to directly modulate brain activity. This method targets specific brain areas involved in Huntington's symptoms, possibly leading to improvements in motor function and cognitive abilities without the systemic side effects of drugs. Plus, tDCS is easy to administer and can be done in short sessions, making it a convenient option compared to more invasive treatments.

What evidence suggests that transcranial direct current stimulation is effective for Huntington's Disease?

Research has shown that transcranial direct current stimulation (tDCS) can improve memory in people with Huntington's Disease. Studies have found that tDCS is safe and might enhance brain functions like memory. Evidence also indicates that tDCS can aid movement skills in individuals with Huntington's. A small study found noticeable improvements in movement, suggesting it might help with movement-related symptoms. In this trial, participants will receive either active tDCS treatment or a sham tDCS treatment to evaluate its effectiveness. Overall, early research suggests tDCS could be beneficial for managing symptoms of Huntington's Disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Thiago Macedo e Cordeiro, MD, MSc

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals with Huntington's Disease, specifically targeting those experiencing cognitive and behavioral symptoms. Participants will use a tDCS device at home and engage in follow-up activities including tests and questionnaires.

Inclusion Criteria

Ability of subject to understand and the willingness to sign a written informed consent document

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

My condition is in the early or moderate stages according to a specific scale.

Exclusion Criteria

History of epilepsy

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)

Being an active participant in other therapeutic clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants receive active or sham tDCS treatment for 30 minutes each day

5 weeks

3 visits (in-person), 3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study is testing the impact of daily 30-minute transcranial direct current stimulation (tDCS) sessions on behavioral symptoms of Huntington's Disease compared to a sham (inactive) treatment.

How Is the Trial Designed?

Group I: Active TDCS treatment Experimental Treatment 1 Intervention

The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation.

Group II: Sham TDCS treatment Placebo Group 1 Intervention

Sham-tDCS treatment will consist of the same montage but the electric current will be applied only in the first and final 30s of stimulation.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Huntingtons Disease Society of America (HDSA)

Collaborator

Trials

2

Recruited

150+

Huntington's Disease Society of America

Collaborator

Published Research Related to This Trial

Cerebellar transcranial Direct Current Stimulation (ctDCS) significantly improved motor scores in four patients with Huntington's Disease, particularly reducing dystonia symptoms, with effects lasting up to four weeks after treatment.

In contrast, sham stimulation did not produce any significant changes in motor scores, highlighting the efficacy of the anodal ctDCS as a potential therapeutic intervention for motor dysfunctions in Huntington's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar Direct Current Stimulation (ctDCS) in the Treatment of Huntington's Disease: A Pilot Study and a Short Review of the Literature. Bocci, T., Baloscio, D., Ferrucci, R., et al.[2020]

A novel imaging method was developed to visualize the current density distribution during transcranial direct current stimulation (tDCS) treatment, using advanced techniques like diffusion tensor imaging and magnetic resonance electrical impedance tomography (MREIT).

The method successfully demonstrated the ability to recover current density distributions in the brain, which is crucial for optimizing tDCS treatment and understanding its effects on different brain structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Density Imaging During Transcranial Direct Current Stimulation Using DT-MRI and MREIT: Algorithm Development and Numerical Simulations. Kwon, OI., Sajib, SZ., Sersa, I., et al.[2022]

Neuroimaging studies have revealed significant brain changes in Huntington's disease, particularly striatal and cortical atrophy, which correlate with cognitive deficits in attention, working memory, and executive functions.

Functional neuroimaging has shown that striatal dysfunction and hypometabolism in the cerebral cortex are linked to executive dysfunction and other cognitive impairments, highlighting the abnormal connectivity between the basal ganglia and cortical areas in HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain imaging and cognitive dysfunctions in Huntington's disease. Montoya, A., Price, BH., Menear, M., et al.[2018]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Transcranial direct current stimulation (tDCS) appears to be well tolerated and safe for children and adolescents with various psychiatric disorders, based on a review of six studies, including three randomized clinical trials.

However, due to the limited number of studies and the need for more rigorous research, definitive conclusions about its efficacy compared to standard treatments cannot yet be made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. Muszkat, D., Polanczyk, GV., Dias, TG., et al.[2018]

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

In a retrospective study of 58 Huntington disease patients treated with deutetrabenazine over an average of 476 days, there was a significant reduction in chorea scores, indicating its effectiveness in managing HD-associated chorea.

The treatment was generally well-tolerated, with a low adverse event rate of 32.8%, and the most common side effects included sedation, insomnia, and diarrhea, supporting its safety profile compared to tetrabenazine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience With Deutetrabenazine for Huntington Disease Chorea. Curtis, K., Sung, V.[2023]

Citations

1. mdpi.com mdpi.com/2077-0383/12/5/2002

Non-Invasive Neuromodulation Methods to Alleviate ... This systematic review aims to investigate the effectiveness of noninvasive neuromodulation in HD-associated motor, cognitive, and behavioral symptoms.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584616304663

Transcranial direct current stimulation can enhance ... Transcranial direct current stimulation may enhance working memory in Huntington's · A double-blind, sham-controlled, crossover trial indicated good tolerability.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28390970/

Transcranial Direct Current Stimulation Can Enhance ... Transcranial Direct Current Stimulation Can Enhance Working Memory in Huntington's Disease. Prog Neuropsychopharmacol Biol Psychiatry. 2017 ...

4. withpower.com withpower.com/trial/phase-huntington-disease-2-2025-66f40

Transcranial Direct Current Stimulation for Huntington's ... Cerebellar transcranial Direct Current Stimulation (ctDCS) significantly improved motor scores in four patients with Huntington's Disease, particularly reducing ...

5. e-jmd.org e-jmd.org/journal/view.php?number=529

Evidence-Based Review on Symptomatic Management ... Transcranial direct current stimulation can enhance working memory in Huntington's disease. Prog Neuropsychopharmacol Biol Psychiatry 2017 ...

6. aetna.com aetna.com/cpb/medical/data/600_699/0614.html

Huntington's Disease - Medical Clinical Policy Bulletins Latorre and colleagues (2019) stated that TMS is a safe and painless non-invasive brain stimulation technique that has been largely used in the past 30 years ...