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

Neuromed IRCCS

Status: Not yet enrolling

Conditions: Huntington Disease

Treatments: Device: Portable ergonomic helmet for real tSMS; Device: portable ergonomic helmet for placebo tSMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06976983

HD2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

HD patients undergo real tSMS

Active Comparator group

Description:

Each HD patients undergo tSMS (real) in two sessions per day, each lasting 60 minutes.

Treatment:

Device: Portable ergonomic helmet for real tSMS

HD patients undergo placebo tSMS

Sham Comparator group

Description:

Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.

Treatment:

Device: portable ergonomic helmet for placebo tSMS