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

N/ANot Yet RecruitingNCT06976983

Neuromed IRCCS30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Huntington Disease

Interventions

Portable ergonomic helmet for real tSMSDEVICE

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 tSMSDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduction of choreic hyperkinesias and akathisia in patients with HD

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.

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

Secondary Outcomes

Modulation of neuropsychiatric symptoms

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.