Transcranial Static Magnetic Stimulation (tSMS) in Huntington's Disease (HD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Portable ergonomic helmet for real tSMS, portable ergonomic helmet for placebo tSMS.
- Who it may be relevant to
- Registry conditions: Huntington Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Transcranial Static Magnetic Stimulation (tSMS) in the Treatment of Hyperkinetic Symptoms of Huntington's Disease
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.
Detailed 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.
Interventions
- Device Portable ergonomic helmet for real 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. - 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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Modulation of neuropsychiatric symptoms [Time frame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Tan B, Shishegar R, Fornito A, Poudel G, Georgiou-Karistianis N. Longitudinal mapping of cortical surface changes in Huntington's Disease. Brain Imaging Behav. 2022 Jun;16(3):1381-1391. doi: 10.1007/s11682-021-00625-2. Epub 2022 Jan 14. PMID 35029800
- Stoker TB, Mason SL, Greenland JC, Holden ST, Santini H, Barker RA. Huntington's disease: diagnosis and management. Pract Neurol. 2022 Feb;22(1):32-41. doi: 10.1136/practneurol-2021-003074. Epub 2021 Aug 19. PMID 34413240
- Spargo E, Everall IP, Lantos PL. Neuronal loss in the hippocampus in Huntington's disease: a comparison with HIV infection. J Neurol Neurosurg Psychiatry. 1993 May;56(5):487-91. doi: 10.1136/jnnp.56.5.487. PMID 8505640
- Rubinsztein DC. How does the Huntington's disease mutation damage cells? Sci Aging Knowledge Environ. 2003 Sep 17;2003(37):PE26. doi: 10.1126/sageke.2003.37.pe26. PMID 13679594
- Quinn N, Schrag A. Huntington's disease and other choreas. J Neurol. 1998 Nov;245(11):709-16. doi: 10.1007/s004150050272. PMID 9808238
- Kremer HP, Roos RA, Dingjan GM, Bots GT, Bruyn GW, Hofman MA. The hypothalamic lateral tuberal nucleus and the characteristics of neuronal loss in Huntington's disease. Neurosci Lett. 1991 Oct 28;132(1):101-4. doi: 10.1016/0304-3940(91)90443-w. PMID 1838577
- Kremer B, Weber B, Hayden MR. New insights into the clinical features, pathogenesis and molecular genetics of Huntington disease. Brain Pathol. 1992 Oct;2(4):321-35. doi: 10.1111/j.1750-3639.1992.tb00709.x. PMID 1341966
- Jose L, Martins LB, Cordeiro TM, Lee K, Diaz AP, Ahn H, Teixeira AL. Non-Invasive Neuromodulation Methods to Alleviate Symptoms of Huntington's Disease: A Systematic Review of the Literature. J Clin Med. 2023 Mar 2;12(5):2002. doi: 10.3390/jcm12052002. PMID 36902788
Identifiers
NCT: NCT06976983 · HD2024