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Enrolling by Invitation

NCT Number: NCT05504902

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrotactile Coordinated Reset

Device

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 outcomes

  1. 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

    This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 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. This assessment is performed while participants are off Parkinson's-related medication.

Secondary outcomes

  1. Levodopa equivalent daily dose (LEDD)

    Time frame: Baseline, 24 months

    LEDD is calculated as a daily sum of levodopa in each Parkinson's medication

  2. Parkinsons disease quality of life questionnaire-39 (PDQ-39)

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

    The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems.

  3. Freezing of Gait Questionnaire (FOG)

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

    The Freezing of Gait questionnaire (FOG) assesses severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score.

  4. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1

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

    The MDS-UPDRS part 1 focuses on non-motor symptoms, such as dementia, depression, and psychosis. The total summed score ranges from 0-52 with higher scores indicating increased non-motor impairment.

  5. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2

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

    The MDS-UPDRS part 2 focuses on the patient's ability to perform daily motor activities including dressing, grooming, and using utensils. The total summed score ranges from 0-52 with higher scores indicating increased daily motor impairment.

  6. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4

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

    The MDS-UPDRS 4 focuses on Measures the complications of treatment, e.g. dyskinesias and motor fluctuations. The total summed score ranges from 0-24 with higher scores indicating increased motor complications.

  7. Communicative Participation Item Bank (CPIB; Short Form)

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

    The CPIB is a questionnaire that measures speech complications. The questionnaire is scored from 0 to 30, with a higher score indicating increased speech difficulties.

  8. Voice Handicap Index (VHI-10)

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

    This questionnaire can be filled out by patients and assesses the impact that voice problems and limitations have on the individual's overall daily function. Questionnaire is scored from 0 to 40, with a higher score indicating increased speech difficulties.

  9. Spontaneous EEG beta band power

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

    Patients will be recorded while receiving vibrotactile stimulation. The Beta Band (13-30Hz) power spectral density (PSD) will be of interest. The units of the power spectral density are micro-Volts-squared per Hz. Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement.

  10. Parkinson's disease cognitive functional rating scale (PD-CFRS)

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

    The PD-CFRS capture subjective daily functional cognitive decline among patients with Parkinson's disease over the past 2 weeks. The scale ranges from 0 to 24, with higher scores indicative of cognitive decline.

  11. Vibratory threshold

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

    Participants will be assessed for their perceptive threshold of vibration, or the lowest vibration amplitude perceived. This is determined by adjusting the amplitude of the experimental device.

  12. 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

    This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 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. This assessment is performed while participants are on Parkinson's-related medication.

Other outcomes

  1. Quantitative Digitography Repetitive Alternating Finger Task (QDG-RAFT)

    Time frame: Baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

    The QDG-RAFT requires participants to place their index and middle finger on adjacent keys of a digitography device. They are instructed to press and release each key in an alternating pattern, as fast and regularly as possible for thirty seconds, starting and stopping only when an auditory cue is heard. This is an exploratory measure.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2022
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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