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Enrolling by invitation NCT05504902

Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

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.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Overview

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR 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.

Detailed description

This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.

Interventions

  • Device Vibrotactile coordinated reset
    The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Advanced stage Parkinson's disease

Primary outcome measures

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
Secondary outcome measures (12)
  • Levodopa equivalent daily dose (LEDD) [Time frame: Baseline, 24 months]
  • Parkinsons disease quality of life questionnaire-39 (PDQ-39) [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Freezing of Gait Questionnaire (FOG) [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Communicative Participation Item Bank (CPIB; Short Form) [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Voice Handicap Index (VHI-10) [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Spontaneous EEG beta band power [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Parkinson's disease cognitive functional rating scale (PD-CFRS) [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Vibratory threshold [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
  • Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) on medication [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]

Eligibility criteria

Inclusion criteria

  • Age at the time of enrollment: 18 years of age or older
  • Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4
  • Fluent in English
  • If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
  • 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.
  • Feels comfortable going off PD related medication during in person study visits.
  • 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
  • Physical limitations unrelated to PD that would affect motor ratings
  • Craniotomy
  • Brain surgery
  • Patient is unable to communicate properly with staff (i.e., severe speech problems)
  • Excessive drooling
  • A type of hair style that would impede the use of an EEG cap
  • Sensory abnormalities of the fingertips
  • Patient is taking a medication that may cause significant withdrawal effects

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: NCT05504902 · 66691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗