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Not yet recruiting NCT05558189

Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibrotactile Coordinated Reset (vCR).
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 35 years — 92 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on refractory post-surgery PD. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

Interventions

  • Device Vibrotactile Coordinated Reset (vCR)
    The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants who have refractory Parkinson's disease post surgical treatment

Primary outcome measures

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months. [Time frame: 24 months]
Secondary outcome measures (11)
  • Levodopa equivalent daily dose (LEDD) change from baseline to 24 months [Time frame: 24 months]
  • Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months. [Time frame: 24 months]
  • Voice Handicap Index (VHI-10) change from baseline to 24 months [Time frame: 24 months]
  • Freezing of gait questionnaire (FOG) change from baseline to 24 months [Time frame: 24 months]
  • Vibratory temporal discrimination task (VTDT) change from baseline to 24 months. [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months. [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months. [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months. [Time frame: 24 months]
  • Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months. [Time frame: 24 months]
  • Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months. [Time frame: 24 months]
  • Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Age at the time of enrollment: 35 - 92 years
  • Diagnosis of idiopathic Parkinson's disease
  • Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
  • Fluent in English
  • Appropriate social support if required during an off state.
  • Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
  • Lives in the United States

Exclusion criteria

  • Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
  • Any current drug or alcohol abuse.
  • Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  • Pregnancy, breast-feeding or wanting to become pregnant
  • Patient is unable to communicate properly with staff (i.e., severe speech problems)
  • Excessive drooling
  • Sensory abnormalities of the fingertips
  • Deep Brain Stimulation treatment
  • PD symptoms so severe and that the patient is bed-bound

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT05558189 · 67601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗