Transcranial Static Magnetic Stimulation (tSMS) in Huntington's Disease (HD)
ConditionHuntington Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNeuromed IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Portable ergonomic helmet for real tSMS
DeviceUnlike 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
DeviceUnlike 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: HD patients undergo real tSMSActive comparator 1 intervention
Group B: HD patients undergo placebo tSMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 stimulationSecondary outcomes
1
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 stimulationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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