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

Sponsor
Neuromed IRCCS
Study ID
NCT06976983
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HD patients undergo real tSMS
    Each HD patients undergo tSMS (real) in two sessions per day, each lasting 60 minutes.
  • Sham Comparator: HD patients undergo placebo tSMS
    Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.

Primary Outcome Measure

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 ]

Central Contacts

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