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

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 more time for follow ups and to undergo additional thinking tests and questionnaires. Participants will also be asked to answer questionnaires over the phone or via a web conferencing platform (Zoom) 3 times during the course of the study. Caregivers of the participants will be asked to complete questionnaires to collect more information about the participants.

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.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) has been studied for various conditions, including Huntington's Disease, and is generally considered safe in humans. In a study involving cerebellar tDCS for Huntington's Disease, no significant safety concerns were reported, suggesting it is well-tolerated. ^{1 2 3 4 5}

How does the treatment Transcranial Direct Current Stimulation (tDCS) differ from other treatments for Huntington's Disease?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a noninvasive treatment that uses a weak electric current applied to the scalp to stimulate specific brain areas, unlike traditional drug treatments. It is relatively safe, easy to use, and has been explored for various neurological and psychiatric conditions, although its effectiveness for Huntington's Disease specifically is still being studied. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for Huntington's Disease?

Research on similar non-invasive brain stimulation techniques, like cerebellar transcranial Direct Current Stimulation (ctDCS), shows improvement in motor symptoms for Huntington's Disease patients. Additionally, a systematic review found that non-invasive neuromodulation methods, including tDCS, have shown some improvement in symptoms, although results vary. ^{1 4 5 11 12}

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Brain imaging and cognitive dysfunctions in Huntington's disease. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Invasive Neuromodulation Methods to Alleviate Symptoms of Huntington's Disease: A Systematic Review of the Literature. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Rapid improvement of depression and psychotic symptoms in Huntington's disease: a retrospective chart review of seven patients treated with electroconvulsive therapy. [2013]

4. Switzerland 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

ECT as a treatment for depression in Huntington's disease. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Real-World Experience With Deutetrabenazine for Huntington Disease Chorea. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Prospective Pilot Trial for Pallidal Deep Brain Stimulation in Huntington's Disease. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Child and Adolescent Psychiatry. [2018]

10. Belgium pubmed.ncbi.nlm.nih.gov

[Transcranial Direct Current Stimulation (tDCS) : psychiatric use]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Current Density Imaging During Transcranial Direct Current Stimulation Using DT-MRI and MREIT: Algorithm Development and Numerical Simulations. [2022]