Parkinson's DiseaseNCT02933476
Vibrotactile Stimulation in Parkinson's Disease
A study testing Vibrotactile Stimulation in people with Parkinson's Disease, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Vibrotactile Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2016
- 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 at least 18 years of age.
- Speaks and understands English.
- A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
- Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
- Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
- Have improvement in motor signs ON versus OFF dopaminergic medication.
- If on medication, the patient should be on stable doses of Sinemet and/or Stalevo (Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen (Patient does not need to be on medication to be included in the study).
Who cannot join
- Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
- Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
- Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
- Subjects who have an inability to comply with study follow-up visits.
- Subjects who are unable to understand or sign the informed consent.
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- Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder.
- Have an active infection.
- Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Movement Disorders Clinic
Stanford, California, 94304
About this study
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.
Read the detailed description
Patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. This testing includes the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will explain the study and obtain informed consent. There will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following: Patients will have sensors put on their hands, feet, and chest. These sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. During this time, patients will be provided with books/movies as entertainment, and they may move around freely. Patients will also be asked to complete several questionnaires throughout the visits about their Parkinson's symptoms.
- Conditions
- Parkinson's Disease
- Being tested
- Vibrotactile Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile StimulationDevice
The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Stimulation Treatment | Experimental | All patients will receive the vibrotactile stimulation treatment. No deception will be used. Receives: Device: Vibrotactile Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Reporting Any Adverse Effects
Questionnaire asks patients to record any adverse effects they experienced.
Measured: 1 Month
Secondary outcomes (3)
Unified Parkinson's Disease Rating Scale, Part III
We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.
Measured: 1 Month
Root Mean Square Velocity
Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.
Measured: 1 Month
Gait Asymmetry
Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- John A Blume Foundation
- Responsible party
- Principal investigator, Helen M. Bronte-Stewart, Stanford University
- Investigators
- Helen Bronte-Stewart, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933476
- Sponsor's protocol ID
- IRB 35238
- Status last verified
- Jan 2018
- First submitted
- 8 Jul 2016
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Adamchic I, Hauptmann C, Barnikol UB, Pawelczyk N, Popovych O, Barnikol TT, Silchenko A, Volkmann J, Deuschl G, Meissner WG, Maarouf M, Sturm V, Freund HJ, Tass PA. Coordinated reset neuromodulation for Parkinson's disease: proof-of-concept study. Mov Disord. 2014 Nov;29(13):1679-84. doi: 10.1002/mds.25923. Epub 2014 Jun 28.
PubMed 24976001Tass PA. A model of desynchronizing deep brain stimulation with a demand-controlled coordinated reset of neural subpopulations. Biol Cybern. 2003 Aug;89(2):81-8. doi: 10.1007/s00422-003-0425-7. Epub 2003 Jul 14.
PubMed 12905037
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02933476
- Acronym / sponsor ID
- IRB 35238
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- John A Blume Foundation
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.
Detailed description
Patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. This testing includes the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will explain the study and obtain informed consent. There will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following: Patients will have sensors put on their hands, feet, and chest. These sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. During this time, patients will be provided with books/movies as entertainment, and they may move around freely. Patients will also be asked to complete several questionnaires throughout the visits about their Parkinson's symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Stimulation Treatment | Experimental | Device: Vibrotactile StimulationAll patients will receive the vibrotactile stimulation treatment. No deception will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age at least 18 years of age.
- Speaks and understands English.
- A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
- Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
- Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
Key exclusion criteria (9 listed)
- Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
- Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
- Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
- Subjects who have an inability to comply with study follow-up visits.
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 |
|---|---|---|
| Vibrotactile StimulationThe tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device. | Device | Vibrotactile Stimulation Treatment |
Primary outcome
Number of Patients Reporting Any Adverse Effects
Time frame: 1 Month
Questionnaire asks patients to record any adverse effects they experienced.
3 secondary outcomes
Unified Parkinson's Disease Rating Scale, Part III
Time frame: 1 Month
Root Mean Square Velocity
Time frame: 1 Month
Gait Asymmetry
Time frame: 1 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24976001Adamchic I, Hauptmann C, Barnikol UB, Pawelczyk N, Popovych O, Barnikol TT, Silchenko A, Volkmann J, Deuschl G, Meissner WG, Maarouf M, Sturm V, Freund HJ, Tass PA. Coordinated reset neuromodulation for Parkinson's disease: proof-of-concept study. Mov Disord. 2014 Nov;29(13):1679-84. doi: 10.1002/mds.25923. Epub 2014 Jun 28.
- Background: PubMed 12905037Tass PA. A model of desynchronizing deep brain stimulation with a demand-controlled coordinated reset of neural subpopulations. Biol Cybern. 2003 Aug;89(2):81-8. doi: 10.1007/s00422-003-0425-7. Epub 2003 Jul 14.
- 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.
Helen Bronte-Stewart, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Stimulation in people with Parkinson's Disease, run by Stanford University 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 23 Jan 2018). 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?
Number of Patients Reporting Any Adverse Effects (time frame: 1 Month). 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 NCT02933476, which also lists 2 linked publications.
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 23 Jan 2018.