Parkinson DiseaseNCT03799614
Vibration Impact on Parkinson's Tremor
A study testing RMBand lower dose and RMBand higher dose in people with Parkinson Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- RMBand lower dose and RMBand higher dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 27 Nov 2019
- 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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease (PD) as diagnosed by a movement disorder specialist
- Tremor caused by their Parkinson's disease
- Ability to provide informed consent
Who cannot join
- Known diagnosis of Parkinson Plus Syndrome
- Dementia
- Other known non-PD cause of tremor
- Other known non-PD cause of limb dysfunction
- Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
- Non-English speaker
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).
Read the detailed description
Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.
- Conditions
- Parkinson Disease
- Being tested
- RMBand lower dose, RMBand higher dose
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMBand lower doseDevice
Light-weight portable device that delivers low dose vibration to the arm
RMBand higher doseDevice
Light-weight portable device that delivers higher dose vibration to the arm
| Study group | Role | What they receive |
|---|---|---|
| Lower dose vibration | Experimental | RMBand lower dose vibration Receives: Device: RMBand lower dose |
| Higher dose vibration | Experimental | RMBand higher dose vibration Receives: Device: RMBand higher dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.
Measured: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
Clinical Rating for Tremor
Clinical Rating Scale for Tremor (Fahn, Tolosa, \& Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.
Measured: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
Objective Measurement of Tremor Frequency (Hz)
This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Measured: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Objective Measurement of Tremor Amplitude (mm).
This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
Measured: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start26 Feb 2019
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
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.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Pretzer-Aboff, PhD, RN, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799614
- Sponsor's protocol ID
- HM20012404
- Status last verified
- Nov 2020
- First submitted
- 19 Dec 2018
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Impact on Parkinson's Tremor
- ClinicalTrials.gov ID
- NCT03799614
- Acronym / sponsor ID
- HM20012404
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).
Detailed description
Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower dose vibration | Experimental | Device: RMBand lower doseRMBand lower dose vibration |
| Higher dose vibration | Experimental | Device: RMBand higher doseRMBand higher dose vibration |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease (PD) as diagnosed by a movement disorder specialist
- Tremor caused by their Parkinson's disease
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Known diagnosis of Parkinson Plus Syndrome
- Dementia
- Other known non-PD cause of tremor
- Other known non-PD cause of limb dysfunction
- Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
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 |
|---|---|---|
| RMBand lower doseLight-weight portable device that delivers low dose vibration to the arm | Device | Lower dose vibration |
| RMBand higher doseLight-weight portable device that delivers higher dose vibration to the arm | Device | Higher dose vibration |
Primary outcome
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time frame: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.
Clinical Rating for Tremor
Time frame: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
Clinical Rating Scale for Tremor (Fahn, Tolosa, \& Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor. Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.
Objective Measurement of Tremor Frequency (Hz)
Time frame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Objective Measurement of Tremor Amplitude (mm).
Time frame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Ingrid Pretzer-Aboff, PhD, RN principal investigator
Virginia Commonwealth 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 RMBand lower dose and RMBand higher dose in people with Parkinson Disease, run by Virginia Commonwealth 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 3 inclusion and 8 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 17 Dec 2020. 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 17 Dec 2020). 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 Disease Rating Scale (MDS-UPDRS) (time frame: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.