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

NCT ID: NCT06976983

Last Updated: 2025-05-16

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Huntington Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type ACTIVE_COMPARATOR

Portable ergonomic helmet for real tSMS

Intervention Type 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.

HD patients undergo placebo tSMS

Each HD patients undergo tSMS (placebo), in two sessions per day, each lasting 60 minutes.

Group Type SHAM_COMPARATOR

portable ergonomic helmet for placebo tSMS

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuromed IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Diego Centonze

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Diego Centonze, MD

Role: CONTACT

+39 0865929703

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.

Reference Type BACKGROUND
PMID: 35029800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34413240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8505640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13679594 (View on PubMed)

Quinn N, Schrag A. Huntington's disease and other choreas. J Neurol. 1998 Nov;245(11):709-16. doi: 10.1007/s004150050272.

Reference Type BACKGROUND
PMID: 9808238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1838577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1341966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36902788 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37629202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38696602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10378380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35609815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38383091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33760890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37023134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16178020 (View on PubMed)

Other Identifiers

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HD2024

Identifier Type: -

Identifier Source: org_study_id

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