tDCS for Huntington's Disease

Overseen By Thiago Macedo e Cordeiro, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Epilepsy, Major cognitive disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

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 will not 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) is generally considered safe, with no reports of serious or lasting harm in over 33,200 sessions involving more than 1,000 people, including vulnerable groups. Common mild side effects include itching, tingling, and headaches, which are usually temporary. ^{1 2 3 4 5}

How does tDCS treatment for Huntington's Disease differ from other treatments?

tDCS (Transcranial Direct Current Stimulation) is unique because it is a non-invasive treatment that uses electrical currents applied to the scalp to modulate brain activity, which is different from traditional drug therapies. It offers a novel approach by potentially allowing more specific neural modulation, especially with high-definition tDCS, which can increase the precision and intensity of the treatment. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment tDCS for Huntington's Disease?

Research on a similar treatment, cerebellar transcranial Direct Current Stimulation (ctDCS), showed improvement in motor scores for Huntington's Disease patients, with effects lasting up to 4 weeks. This suggests that non-invasive brain stimulation techniques like tDCS may have potential benefits for Huntington's Disease. ^{11 12 13 14 15}

Who Is on the Research Team?

Erin Stimming, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

You have a risk of thinking about or doing things to harm yourself.

I have been diagnosed with a major cognitive disorder or dementia.

Unstable medical conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based transcranial direct current stimulation (tDCS) for Huntington's Disease-related symptoms

8 weeks

Baseline, week 2, week 4, week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person or virtual) at 4 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• active tDCS

Trial Overview 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.

How Is the Trial Designed?

Group I: active tDCS Experimental Treatment 1 Intervention

active tDCS is already approved in Canada for the following indications:

Approved in Canada as tDCS for:

• Depression in pregnancy

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a 2-year study of 20 patients with Huntington's disease, specific electrophysiological tests showed significant deterioration over time, indicating a correlation with clinical decline in motor and functional abilities.

Electrophysiological parameters, such as blink reflex latency and somatosensory evoked potentials, may serve as objective markers for tracking disease progression in Huntington's disease, reflecting changes in neural circuit function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological deterioration over time in patients with Huntington's disease. Lefaucheur, JP., Ménard-Lefaucheur, I., Maison, P., et al.[2006]

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 study involving 17 participants with Huntington's disease, alpha-frequency transcranial alternating current stimulation (tACS) significantly increased brain activity related to apathy, as measured by the Contingent Negative Variation (CNV) response, while delta-frequency and sham stimulation did not show this effect.

Neurotypical controls did not exhibit changes in brain activity from tACS, but they did show faster response times after alpha-tACS, suggesting that this frequency may enhance cognitive processing in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medial prefrontal transcranial alternating current stimulation for apathy in Huntington's disease. Davis, MC., Hill, AT., Fitzgerald, PB., et al.[2023]

Electrophysiological tests, especially somatosensory evoked potentials (SEPs) and blink reflexes (BRs), were found to be sensitive indicators of disease progression in 36 patients with early-stage Huntington's disease, with SEPs showing abnormalities in 94% of participants.

These tests correlated with clinical assessments of motor symptoms, suggesting that incorporating electrophysiological evaluations into follow-up programs could enhance monitoring and understanding of Huntington's disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical relevance of electrophysiological tests in the assessment of patients with Huntington's disease. Lefaucheur, JP., Bachoud-Levi, AC., Bourdet, C., et al.[2006]

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]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Transcranial direct current stimulation (tDCS) is a safe intervention for pediatric motor disorders, with no significant difference in dropout rates between active and sham groups, and only mild adverse effects reported, such as tingling and discomfort.

In children with cerebral palsy, tDCS significantly improved gait velocity, stride length, and cadence, suggesting it may enhance certain motor functions, although its effectiveness on balance and upper extremity function remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. Saleem, GT., Crasta, JE., Slomine, BS., et al.[2021]

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]

The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.

HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]

High-definition transcranial direct current stimulation (HD-tDCS) is feasible and acceptable for patients with chronic post-stroke aphasia, showing that it can be implemented effectively in a clinical setting with similar protocols to conventional sponge-based tDCS.

Preliminary results indicate that HD-tDCS may improve naming accuracy and response time in patients, with some evidence suggesting it could be more effective than conventional tDCS, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. Richardson, J., Datta, A., Dmochowski, J., et al.[2023]

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]

A review of 15 studies on transcranial direct current stimulation (tDCS) before 1998 found that most trials (about 83%) focused on treating psychiatric conditions like depression and schizophrenia, with 12 out of 15 studies showing positive outcomes.

While the stimulation intensities used in older studies were lower than modern standards, the longer session durations and higher current densities suggest that these factors may have contributed to the encouraging results and mild side effects reported, such as headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. Esmaeilpour, Z., Schestatsky, P., Bikson, M., et al.[2022]

Citations

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

Electrophysiological deterioration over time in patients with Huntington's disease. [2006]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Medial prefrontal transcranial alternating current stimulation for apathy in Huntington's disease. [2023]

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

Clinical relevance of electrophysiological tests in the assessment of patients with Huntington's disease. [2006]

5. Canada pubmed.ncbi.nlm.nih.gov

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

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

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

Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. [2021]

11. 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]

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

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. [2023]

14. 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]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. [2022]