Clinical trial NCT05502432: Repetitive Transcranial Magnetic Stimulation in SCA3 Patients
Official title: A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxia Type 3
Keywords: Device:Active repetitive transcranial magnetic stimulation
Device:Sham repetitive transcranial magnetic stimulation
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide.Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy used to treat depression and cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15 day treatment with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) can improve symptoms (motor symptoms and non-motor symptoms) in patients with MJD.

Detailed description: Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common spinocerebellar ataxia worldwide. MJD shows remarked clinical heterogeneity and presents with various clinical manifestations, including cerebellar ataxia, limb incoordination, dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. No effective treatment is currently available for MJD.

Repetitive transcranial magnetic stimulation (rTMS)enables non-invasive modulation of cortical excitability. rTMS targeting cerebellar structures is capable of inducing long-lasting changes in the excitability of cerebello-thalamocortical pathways.

Subjects will be randomized in two groups, one receiving a consecutive 15-day treatment with 1 Hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation with identical parameters. Patients will be clinically assessed at baseline, during intervention period at 7 days and 15 days immediate after treatment.

Eligibility criteria: Inclusion Criteria:

1 .Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3.

2. SCA3 patients aged 20 - 80 years 3. Patients or their family members have informed consent to the study and signed relevant documents

Exclusion Criteria:

* 1. Patients who have concomitant epilepsy. 2. History of seizure or heat convulsion. 3. Patients on neuroleptics. 4. History or current unstable hypertension. 5. History of head injury or neurosurgical interventions. 6. History of any metal in the head (outside the mouth). 7. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

  8. History of frequent or severe headaches. 9. History of migraine. 10. History of hearing loss. 11. History of cochlear implants 12. History of drug abuse or alcoholism. 13. Pregnancy or not using a reliable method of birth control. 14. Participation in current clinical study.

Primary outcomes:
measure: ICARS
timeFrame: At baseline, during intervention period at 7 days and 15 days immediate after treatment.
Secondary outcomes:
measure: BBS
timeFrame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
measure: SARA
timeFrame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
Other outcomes:
measure: Tandem gait
timeFrame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
measure: 10 Metre Walk Test
timeFrame: At baseline, during intervention period at 7 days and 15 days immediate after treatment
measure: Static Stability Test
timeFrame: At baseline and 15 days immediate after treatment
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline and 15 days immediate after treatment
measure: Athens Insomnia Scale (AIS)
timeFrame: At baseline and 15 days immediate after treatment
measure: Mini-Mental State Examination (MMSE)
timeFrame: At baseline and 15 days immediate after treatment
measure: Montreal Cognitive Assessment (MoCA）
timeFrame: At baseline and 15 days immediate after treatmen
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: At baseline and 15 days immediate after treatmen
measure: Hamilton Depression Scale (HAMD)
timeFrame: At baseline and 15 days immediate after treatmen
Locations:
city: Fuzhou
country: China
facility: Department of Neurology ,First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
citation: Shiga Y, Tsuda T, Itoyama Y, Shimizu H, Miyazawa KI, Jin K, Yamazaki T. Transcranial magnetic stimulation alleviates truncal ataxia in spinocerebellar degeneration. J Neurol Neurosurg Psychiatry. 2002 Jan;72(1):124-6. doi: 10.1136/jnnp.72.1.124. No abstract available.
citation: Manor B, Greenstein PE, Davila-Perez P, Wakefield S, Zhou J, Pascual-Leone A. Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Feb 12;10:73. doi: 10.3389/fneur.2019.00073. eCollection 2019.
citation: Shimizu H, Tsuda T, Shiga Y, Miyazawa K, Onodera Y, Matsuzaki M, Nakashima I, Furukawa K, Aoki M, Kato H, Yamazaki T, Itoyama Y. Therapeutic efficacy of transcranial magnetic stimulation for hereditary spinocerebellar degeneration. Tohoku J Exp Med. 1999 Nov;189(3):203-11. doi: 10.1620/tjem.189.203.