Parkinson DiseaseNCT03857867

Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease

A study testing Tactile Stimulation Glove in people with Parkinson Disease, run by Peter Tass, MD, PhD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Tactile Stimulation Glove
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2019to 30 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 and older
Diagnosis of idiopathic Parkinson's disease.
Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
Able to provide informed consent.
Appropriate social support

Who cannot join

Hoehn and Yahr stage greater than 3 in the on medication state
Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
Any illness that in the investigator's opinion precludes participation in the study
Subjects unable to communicate with the investigator and staff

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease

This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.

Read the detailed description

This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.

Conditions: Parkinson Disease
Being tested: Tactile Stimulation Glove
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tactile Stimulation GloveDevice
A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.

Study groups in NCT03857867
Study group	Role	What they receive
Tactile Stimulation Glove	Experimental	Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months Receives: Device: Tactile Stimulation Glove

What is being measured

The primary outcome is the main question the study is designed to answer.

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
Measured: Baseline, 3 months

Secondary outcomes (2)

Levodopa Equivalent Daily Dose
Levodopa equivalent daily dose (LEDD) was measured at baseline and after 3 months of vibrotactile coordinated reset therapy. LEDD is calculated as a sum of each Parkinson's medication.
Measured: Baseline, 3 months
Electroencephalography (EEG) Sensorimotor Relative Power Activity
Measure Description: Baseline EEG was recorded. EEG source estimation was computed using Standardized low-resolution brain electromagnetic tomography analysis (sLORETA) and was restricted to the sensorimotor region. Power spectral density (PSD) was calculated for each frequency band (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; Gamma: 31-50 Hz). Relative power (RP) was calculated by taking the sum of each frequency and dividing it by the total power (2-50 Hz) expressed as a percentage. High beta power was the frequency band of interest for analysis.
Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201930 Dec 2020

First posted28 Feb 2019
Study start1 Feb 2019
Primary completion30 Dec 2020
Study completion30 Dec 2020

Why it stopped: Covid 19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03857867
Sponsor's protocol ID: IRB-47775
Status last verified: Nov 2021
First submitted: 26 Feb 2019
Last updated: 21 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pfeifer KJ, Kromer JA, Cook AJ, Hornbeck T, Lim EA, Mortimer BJP, Fogarty AS, Han SS, Dhall R, Halpern CH, Tass PA. Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Front Physiol. 2021 Apr 6;12:624317. doi: 10.3389/fphys.2021.624317. eCollection 2021.
PubMed 33889086

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease
ClinicalTrials.gov ID: NCT03857867
Acronym / sponsor ID: IRB-47775
Conditions: Parkinson Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Covid 19
Enrolment: 7 participants (actual)
Lead sponsor: Peter Tass, MD, PhDUniversity, hospital or other
Study start: 1 Feb 2019 (actual)
Primary completion: 30 Dec 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 28 Feb 2019 (actual)
Results: Posted 21 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tactile Stimulation Glove	Experimental	Device: Tactile Stimulation GlovePatient will receive active stimulation for a minimum of 3 months and a maximum of 13 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18 and older
Diagnosis of idiopathic Parkinson's disease.
Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
Able to provide informed consent.

Key exclusion criteria (4 listed)

Hoehn and Yahr stage greater than 3 in the on medication state
Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
Any illness that in the investigator's opinion precludes participation in the study
Subjects unable to communicate with the investigator and staff

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tactile Stimulation GloveA glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.	Device	Tactile Stimulation Glove

Primary outcome

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Time frame: Baseline, 3 months
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.

2 secondary outcomes

Levodopa Equivalent Daily Dose
Time frame: Baseline, 3 months
Electroencephalography (EEG) Sensorimotor Relative Power Activity
Time frame: Baseline, 3 months

Results and safety

Results posted to the registry on 21 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tactile Stimulation Glove	7	6

Primary outcome: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score

Time frame: Baseline, 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Tactile Stimulation Glove n = 6
Baseline	38.33 (5.93)
3 months	32.33 (7.80)

Population analysed: Participants who completed baseline and the 3 month follow up are included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 13 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tactile Stimulation Glove	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): The study did not meet its accrual goal of 20 participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33889086Pfeifer KJ, Kromer JA, Cook AJ, Hornbeck T, Lim EA, Mortimer BJP, Fogarty AS, Han SS, Dhall R, Halpern CH, Tass PA. Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Front Physiol. 2021 Apr 6;12:624317. doi: 10.3389/fphys.2021.624317. eCollection 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tactile Stimulation Glove in people with Parkinson Disease, run by Peter Tass, MD, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.