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Not yet recruiting NCT06559098

Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation

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: 18 years — 100 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
Center list to be confirmed — check the primary protocol.
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 this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.

Interventions

  • Device Vibrotactile coordinated reset (vCR)
    Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain

Primary outcome measures

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication [Time frame: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months]
Secondary outcome measures (11)
  • Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months [Time frame: 24 months]
  • Parkinson's disease quality of life questionnaire-39 (PDQ-39) [Time frame: 24 months]
  • Freezing of Gait Questionnaire (FOG) change [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 [Time frame: 24 months]
  • Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change [Time frame: 24 months]
  • Communicative Participation Item Bank (CPIB; Short Form) [Time frame: 24 months]
  • Voice Handicap Index (VHI-10) [Time frame: 24 months]
  • Spontaneous Electroencephalography beta band power change [Time frame: 24 months]
  • Parkinson's disease cognitive functional rating scale (PD-CFRS) [Time frame: 24 months]
  • Device calibration [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Any adult age 18 and 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 Electroencephalography (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 Parkinson's Disease(PD) related medication during in person study visits
  • Lives in the United States
  • Having previously been enrolled in a vCR pilot study

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 hairstyle 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.
  • Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06559098 · 71579

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗