Clinical trial NCT06976983: Transcranial Static Magnetic Stimulation (tSMS) in Huntington's Disease (HD)
Official title: Effects of Transcranial Static Magnetic Stimulation (tSMS) in the Treatment of Hyperkinetic Symptoms of Huntington's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Huntington Disease
Keywords: huntington disease
transcranial stimulation with static magnetic field
hyperckinesia
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Reduction of choreic hyperkinesias and akathisia in patients with HD
timeFrame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation
Secondary outcomes:
measure: Modulation of neuropsychiatric symptoms
timeFrame: The project aims to evaluate the efficacy of tSMS in reducing choreic hyperkinesias in patients after 1 month stimulation
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Quinn N, Schrag A. Huntington's disease and other choreas. J Neurol. 1998 Nov;245(11):709-16. doi: 10.1007/s004150050272.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.