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N/A Completed N=5 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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