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| ID | Type | Description | Link |
|---|---|---|---|
| 9205 | Other Grant/Funding Number | Michael J. Fox Foundation |
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
| Hospital Nacional de Parapléjicos de Toledo | OTHER |
| Hospital San Carlos, Madrid | OTHER |
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tSMS | Experimental | 30 min of tSMS, one session per day, for 9 days over 2 weeks |
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| sham | Placebo Comparator | 30 min of sham, one session per day, for 9 days over 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tSMS | Device | Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment. | One day after the end of treatment compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment. | One week after the end of treatment compared to baseline | |
| Dyskinesia severity evaluated for each body segment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guglielmo Foffani, PhD | CINAC, Hospital Universitario HM Puerta del Sur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CINAC, Hospital Universitario Puerta del Sur | Móstoles | Madrid | 28938 | Spain |
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| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| sham | Device | A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain). |
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| Baseline, one day and one week after the end of treatment |
| Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC) | One day and one week after the end of treatment |
| Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale | Baseline, one day and one week after the end of treatment |
| D009461 |
| Neurologic Manifestations |
| D020258 | Neurotoxicity Syndromes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |