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Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

Primary Purpose

Spinocerebellar Ataxia Type 3

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
Ning Wang, MD., PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinocerebellar Ataxia Type 3 focused on measuring Device:Active repetitive transcranial magnetic stimulation, Device:Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology ,First Affiliated Hospital Fujian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Repetitive Transcranial Magnetic Stimulation(rTMS)

Sham Repetitive Transcranial Magnetic Stimulation(rTMS)

Arm Description

15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.

15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.

Outcomes

Primary Outcome Measures

ICARS
The International Cooperative Ataxia Rating Scale (ICARS)

Secondary Outcome Measures

BBS
Berg Balance Scale (BBS)
SARA
Scale for the Assessment and Rating of Ataxia (SARA)

Full Information

First Posted
September 19, 2019
Last Updated
August 14, 2022
Sponsor
Ning Wang, MD., PhD.
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1. Study Identification

Unique Protocol Identification Number
NCT05502432
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ning Wang, MD., PhD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Ataxia Type 3
Keywords
Device:Active repetitive transcranial magnetic stimulation, Device:Sham repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Repetitive Transcranial Magnetic Stimulation(rTMS)
Arm Type
Active Comparator
Arm Description
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with active mood.
Arm Title
Sham Repetitive Transcranial Magnetic Stimulation(rTMS)
Arm Type
Sham Comparator
Arm Description
15 days with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) with sham mood.
Intervention Type
Device
Intervention Name(s)
Active repetitive transcranial magnetic stimulation
Intervention Description
Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Intervention Description
Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
ICARS
Description
The International Cooperative Ataxia Rating Scale (ICARS)
Time Frame
At baseline, during intervention period at 7 days and 15 days immediate after treatment.
Secondary Outcome Measure Information:
Title
BBS
Description
Berg Balance Scale (BBS)
Time Frame
At baseline, during intervention period at 7 days and 15 days immediate after treatment
Title
SARA
Description
Scale for the Assessment and Rating of Ataxia (SARA)
Time Frame
At baseline, during intervention period at 7 days and 15 days immediate after treatment
Other Pre-specified Outcome Measures:
Title
Tandem gait
Description
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.
Time Frame
At baseline, during intervention period at 7 days and 15 days immediate after treatment
Title
10 Metre Walk Test
Description
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.
Time Frame
At baseline, during intervention period at 7 days and 15 days immediate after treatment
Title
Static Stability Test
Description
Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance.
Time Frame
At baseline and 15 days immediate after treatment
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Time Frame
At baseline and 15 days immediate after treatment
Title
Athens Insomnia Scale (AIS)
Description
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).
Time Frame
At baseline and 15 days immediate after treatment
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
At baseline and 15 days immediate after treatment
Title
Montreal Cognitive Assessment (MoCA）
Description
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.
Time Frame
At baseline and 15 days immediate after treatmen
Title
Hamilton Anxiety Scale (HAMA)
Description
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).
Time Frame
At baseline and 15 days immediate after treatmen
Title
Hamilton Depression Scale (HAMD)
Description
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).
Time Frame
At baseline and 15 days immediate after treatmen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Neurology ,First Affiliated Hospital Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
11784843
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.
Results Reference
background
PubMed Identifier
30809184
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.
Results Reference
background
PubMed Identifier
10674722
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.
Results Reference
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Repetitive Transcranial Magnetic Stimulation in SCA3 Patients

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