Spinocerebellar Ataxia Type 3
Conditions
Keywords
Device:Active repetitive transcranial magnetic stimulation, Device:Sham repetitive transcranial magnetic stimulation
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.
Interventions
Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation
DEVICESham repetitive transcranial magnetic stimulation
Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation
Sponsors
Ning Wang, MD., PhD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICARS | At baseline, during intervention period at 7 days and 15 days immediate after treatment. | The International Cooperative Ataxia Rating Scale (ICARS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BBS | At baseline, during intervention period at 7 days and 15 days immediate after treatment | Berg Balance Scale (BBS) |
| SARA | At baseline, during intervention period at 7 days and 15 days immediate after treatment | Scale for the Assessment and Rating of Ataxia (SARA) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | At baseline and 15 days immediate after treatment | 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 |
| Athens Insomnia Scale (AIS) | At baseline and 15 days immediate after treatment | 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). |
| Mini-Mental State Examination (MMSE) | At baseline and 15 days immediate after treatment | 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. |
| Tandem gait | At baseline, during intervention period at 7 days and 15 days immediate after treatment | 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. |
| Hamilton Anxiety Scale (HAMA) | At baseline and 15 days immediate after treatmen | 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). |
| Hamilton Depression Scale (HAMD) | At baseline and 15 days immediate after treatmen | 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). |
| Montreal Cognitive Assessment (MoCA） | At baseline and 15 days immediate after treatmen | 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. |
| 10 Metre Walk Test | At baseline, during intervention period at 7 days and 15 days immediate after treatment | 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. |
| Static Stability Test | At baseline and 15 days immediate after treatment | Static Stability Test is a objective test use Pro-kin machine to evaluate patient's standing balance. |
Countries
China
Outcome results
None listed