Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About this trial

The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age at the time of enrollment: Adults 18 and older

Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4

Fluent in English

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Vibrotactile Coordinated Reset

    Device

    The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MDS-UPDRS Part 3

The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.

Time frame
Baseline, 6 months, 12 months, 18 months, 24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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