Parkinson Disease Clinical Trial
Verified date | March 2019 |
Source | Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI
Status | Completed |
Enrollment | 46 |
Est. completion date | January 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders. - Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic therapy (at a minimum, on levodopa and/or dopamine agonist therapy). - On a stable dose of all medications for 2 months; and no anti-PD medication adjustments in the next 3 months. - Age 40 years or older. - Mini-mental state examination > 27. Exclusion Criteria: - Any history or clinical signs of other severe psychiatric illnesses (like major depression, psychosis or obsessive compulsive disorder). - History of head injury, stroke, or other neurologic disease. - Organic brain defects on T1 or T2 images. - History of seizures or unexplained loss of consciousness. - Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator. - Family history of medication refractory epilepsy. - History of substance abuse within the last 6 months. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III | This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms. | changes from baseline at 2 weeks post-treatment | |
Secondary | Timed up and go test | Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again. | changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment | |
Secondary | 20m walking test | The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again. | changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment | |
Secondary | Non-motor symptoms questionnaire | This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms. | changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment | |
Secondary | Unified Parkinson's Disease Rating Scale III | This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms. | changes from baseline at 1, 4, 6, and 10 weeks post-treatment |
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