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

NCT06976983 | Not Yet Recruiting

• 1 other identifier: HD2024
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Huntington Disease

Keywords

huntington disease; transcranial stimulation with static magnetic field; hyperckinesia

Outcome Measures

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.

  The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation

Secondary Outcomes (1)

• Modulation of neuropsychiatric symptoms

  The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation

Study Arms (2)

HD patients undergo real tSMS

ACTIVE COMPARATOR

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

Device: Portable ergonomic helmet for real tSMS

HD patients undergo placebo tSMS

SHAM COMPARATOR

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

Device: portable ergonomic helmet for placebo tSMS

Interventions

Portable ergonomic helmet for real tSMS 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 real tSMS

portable ergonomic helmet for placebo tSMS 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromed IRCCS: lead

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 9808238 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37629202 BACKGROUND

• 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.

  PMID: 38696602 BACKGROUND

• 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.

  PMID: 10378380 BACKGROUND

• 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.

  PMID: 35609815 BACKGROUND

• 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.

  PMID: 38383091 BACKGROUND

• 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.

  PMID: 33760890 BACKGROUND

• 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.

  PMID: 37023134 BACKGROUND

• 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.

  PMID: 16178020 BACKGROUND

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Diego Centonze, MD

CONTACT

+39 0865929703; trial.clinici1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: May 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05