Transcranial Static Magnetic Stimulation (tSMS) in Huntington's Disease (HD)

Huntington's disease (HD) is a neurodegenerative pathology characterized by choreic hyperkinesias which represent the typical motor symptom and are represented by involuntary, aimless, irregular, recurrent, unpredictable and non-rhythmic movements of the trunk, face and limbs.

Non-invasive brain neuromodulation has been proposed as a possible treatment for involuntary movements in several clinical conditions including HD.

The objective of the study is to evaluate the effect of home treatment with repeated sessions of transcranial static magnetic field stimulation (tSMS) in safely reducing choreic hyperkinesis in HD patients.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A two-week course of repetitive magnetic stimulation (rTMS) has been shown to exert persistent clinical beneficial effects, reducing peak drug dyskinesias for up to four weeks after the end of the stimulation period. rTMS has also been reported to have a beneficial effect in HD. In particular, the stimulation showed a significant reduction in involuntary movements in a group of symptomatic patients.

Unlike rTMS, tSMS is attracting considerable interest because it is more manageable and easier to apply. This is a method applicable using a portable ergonomic helmet that shifts the paradigm of non-invasive brain stimulation (NIBS) from a center-based therapeutic model to a home-based one.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of HD genetically confirmed (number of CAG triplets ≥36)
Presence of chorea movements quantified with a score ≥ 10 on the sum of the scores of the subscale of the Unified Huntington's Disease Rating Scale (UHDRS) for the evaluation of maximum chorea for the facial, oro-bucco-lingual, truncal, four limbs districts
Ability to provide written informed consent
No changes in drug therapy in the 8 weeks prior to the baseline visit
No changes in drug therapy for the entire duration of the study

Exclusion criteria

Contraindications to exposure to magnetic fields
Patients who are pregnant or breastfeeding
Presence of significant risk of suicidal behavior
Patients who have received an investigational drug in a clinical trial within 30 days of the baseline visit or have planned to use such an investigational drug during the study

Treatment and study plan

Portable ergonomic helmet for real tSMS

Device

Unlike repetitive magnetic stimulation (rTMS), tSMS is attracting considerable interest because it is more manageable and easy to apply. It is a method applicable through a portable ergonomic helmet that shifts the paradigm of non-invasive brain stimulation (NIBS) from a center-based therapeutic model to a home-based one.

portable ergonomic helmet for placebo tSMS

Device

Primary outcomes

Reduction of choreic hyperkinesias and akathisia in patients with HD

Time frame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation

The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in 30 patients with HD. The Unified Huntington's Disease Rating Scale will be used to assessed maximal chorea in different body districts (face, bucco-oral-lingual, trunk, upper and lower extremity) before and after treatment. Akathisia will be instead determined with the Barnes Akathisia Rating Scale.

Secondary outcomes

Modulation of neuropsychiatric symptoms

Time frame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation

As a further objective, the project aims to evaluate the possible modulation of neuropsychiatric symptoms commonly associated with the disease by using the Beck Depression Inventory-II, State-Trait Anxiety Inventory and Columbia Suicide Severity Rating Scale.

tSMS is a non-invasive method and almost free of adverse events if administered in well-selected patients. This method could represent a complement to pharmacological therapy in the advanced stages or, possibly, replace it in the early stages of the disease by reducing the potential side effects secondary to prolonged pharmacological treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Centonze, MD

CONTACT

[email protected]

+39 0865929703

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Official study title

Effects of Transcranial Static Magnetic Stimulation (tSMS) in the Treatment of Hyperkinetic Symptoms of Huntington's Disease

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 16, 2025
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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