Transcranial Static Magnetic Stimulation (tSMS) in Huntington's Disease (HD)
NCT ID: NCT06976983
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HD patients undergo real tSMS
Each HD patients undergo tSMS (real) in two sessions per day, each lasting 60 minutes.
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.
HD patients undergo placebo tSMS
Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Neuromed IRCCS
OTHER
Responsible Party
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Diego Centonze
MD, Principal Investigator
Central Contacts
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References
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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.
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.
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.
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.
Quinn N, Schrag A. Huntington's disease and other choreas. J Neurol. 1998 Nov;245(11):709-16. doi: 10.1007/s004150050272.
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.
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.
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.
Jiang A, Handley RR, Lehnert K, Snell RG. From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington's Disease Research. Int J Mol Sci. 2023 Aug 21;24(16):13021. doi: 10.3390/ijms241613021.
Hensel L, Ludtke J, Brouzou KO, Eickhoff SB, Kamp D, Schilbach L. Noninvasive brain stimulation in autism: review and outlook for personalized interventions in adult patients. Cereb Cortex. 2024 May 2;34(13):8-18. doi: 10.1093/cercor/bhae096.
Heinsen H, Rub U, Bauer M, Ulmar G, Bethke B, Schuler M, Bocker F, Eisenmenger W, Gotz M, Korr H, Schmitz C. Nerve cell loss in the thalamic mediodorsal nucleus in Huntington's disease. Acta Neuropathol. 1999 Jun;97(6):613-22. doi: 10.1007/s004010051037.
Dileone M, Ammann C, Catanzaro V, Pagge C, Piredda R, Monje MHG, Navalpotro-Gomez I, Bergareche A, Rodriguez-Oroz MC, Vela-Desojo L, Alonso-Frech F, Catalan MJ, Molina JA, Lopez-Ariztegu N, Oliviero A, Obeso JA, Foffani G. Home-based transcranial static magnetic field stimulation of the motor cortex for treating levodopa-induced dyskinesias in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2022 May-Jun;15(3):857-860. doi: 10.1016/j.brs.2022.05.012. Epub 2022 May 21. No abstract available.
Cole E, O'Sullivan SJ, Tik M, Williams NR. Accelerated Theta Burst Stimulation: Safety, Efficacy, and Future Advancements. Biol Psychiatry. 2024 Mar 15;95(6):523-535. doi: 10.1016/j.biopsych.2023.12.004.
Calderon-Villalon J, Ramirez-Garcia G, Fernandez-Ruiz J, Sangri-Gil F, Campos-Romo A, Galvez V. Planning deficits in Huntington's disease: A brain structural correlation by voxel-based morphometry. PLoS One. 2021 Mar 24;16(3):e0249144. doi: 10.1371/journal.pone.0249144. eCollection 2021.
Caballero-Insaurriaga J, Pineda-Pardo JA, Obeso I, Oliviero A, Foffani G. Noninvasive modulation of human corticostriatal activity. Proc Natl Acad Sci U S A. 2023 Apr 11;120(15):e2219693120. doi: 10.1073/pnas.2219693120. Epub 2023 Apr 6.
Brusa L, Versace V, Koch G, Bernardi G, Iani C, Stanzione P, Centonze D. Improvement of choreic movements by 1 Hz repetitive transcranial magnetic stimulation in Huntington's disease patients. Ann Neurol. 2005 Oct;58(4):655-6. doi: 10.1002/ana.20613. No abstract available.
Other Identifiers
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HD2024
Identifier Type: -
Identifier Source: org_study_id
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