An interventional study of Portable ergonomic helmet for real tSMS and portable ergonomic helmet for placebo tSMS in Huntington Disease, sponsored by Neuromed IRCCS. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Neuromed IRCCS · Not applicable, Interventional, and Treatment
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.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Neuromed IRCCS is the lead sponsor of 81 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each HD patients undergo tSMS (real) in two sessions per day, each lasting 60 minutes.
Device: Portable ergonomic helmet for real tSMS
Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.
Device: portable ergonomic helmet for placebo tSMS
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.
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.
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
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.
Time frame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation
No study locations are listed for this record.
Start is estimated for Sep 2025; primary completion for Apr 2026, 7 months later.
Of 33 interventional studies with no phase under Huntington Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 36. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Neuromed IRCCS