Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Spinocerebellar Ataxia Type 3 Clinical Trial

Official title:

A Prospective, Randomized, Controlled Trial for the Efficacy of Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia Type 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502432
• Other study ID #: chiCTR180002013
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2022
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 30, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Machado-Joseph Disease
• Spinocerebellar Ataxia Type 3
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Device:
• Active repetitive transcranial magnetic stimulation
Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation
• Sham repetitive transcranial magnetic stimulation
Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
China	Department of Neurology ,First Affiliated Hospital Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Ning Wang, MD., PhD.

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tandem gait	Tandem gait is a gait (method of walking or running) where the toes of the back foot touch the heel of the front foot at each step.	At baseline, during intervention period at 7 days and 15 days immediate after treatment
Other	10 Metre Walk Test	The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	At baseline, during intervention period at 7 days and 15 days immediate after treatment
Other	Static Stability Test	Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance.	At baseline and 15 days immediate after treatment
Other	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used instrument to assess the subjective sleep quality of adults in clinical and community settings	At baseline and 15 days immediate after treatment
Other	Athens Insomnia Scale (AIS)	The AIS is a self-reported questionnaire designed to measure the severity of insomnia based on the diagnostic criteria of the International Classification of Diseases, 10th revision (ICD-10).	At baseline and 15 days immediate after treatment
Other	Mini-Mental State Examination (MMSE)	In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.	At baseline and 15 days immediate after treatment
Other	Montreal Cognitive Assessment (MoCA)	In addressing cognitive screening tools, the MMSE and the MoCA are the most commonly used methods in cognitive impairment detection in both clinical and research fields.	At baseline and 15 days immediate after treatmen
Other	Hamilton Anxiety Scale (HAMA)	HAMA contains 14 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMA is operationally categorized as follows: no anxiety (score 0-6), mild and moderate anxiety (score 7-13), severe anxiety (score = 14).	At baseline and 15 days immediate after treatmen
Other	Hamilton Depression Scale (HAMD)	HAMD contains 17 questions; each question includes 5 items. Responses are scored as 0 (never), 1 (mild), 2 (moderate), 3 (severe), or 4 (extremely serious). The total score of HAMD can be classified into normal (score 0-6), mild and moderate (score 7-23), severe depression (score = 24).	At baseline and 15 days immediate after treatmen
Primary	ICARS	The International Cooperative Ataxia Rating Scale (ICARS)	At baseline, during intervention period at 7 days and 15 days immediate after treatment.
Secondary	BBS	Berg Balance Scale (BBS)	At baseline, during intervention period at 7 days and 15 days immediate after treatment
Secondary	SARA	Scale for the Assessment and Rating of Ataxia (SARA)	At baseline, during intervention period at 7 days and 15 days immediate after treatment