N/A
Completed N=5
Vibrotactile Stimulation in Parkinson's Disease
Source: ClinicalTrials.gov NCT02933476 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Number of Patients Reporting Any Adverse Effects — 0 Participants
Summary
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting Any Adverse Effects |
— | — |
| SECONDARY Unified Parkinson's Disease Rating Scale, Part III |
21; 21.8; 20.8 | >0.05 |
| SECONDARY Root Mean Square Velocity |
350.637; 456.736 | 0.008 sig |
| SECONDARY Gait Asymmetry |
4.53; 8.51 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Age at least 18 years of age.
- Speaks and understands English.
- A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
- Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
- Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
- Have improvement in motor signs ON versus OFF dopaminergic medication.
- If on medication, the patient should be on stable doses of Sinemet and/or Stalevo (Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen (Patient does not need to be on medication to be included in the study).
Exclusion Criteria
- Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
- Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
- Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
- Subjects who have an inability to comply with study follow-up visits.
- Subjects who are unable to understand or sign the informed consent.
- Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder.
- Have an active infection.
- Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
Data sourced from ClinicalTrials.gov (NCT02933476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.