Parkinson DiseaseNCT05106816
The Effects of Vibrotactile Stimulation in Patients With Movement Disorders
A study testing skin surface vibration in people with Parkinson Disease and Essential Tremor, run by University of Florida at 1 site in United States.
Trial summary
Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- What is being tested?
- skin surface vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 and able to provide informed consent.
- Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist.
- Medically optimized without planned medication changes for the duration of the study.
- For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale.
- For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor
Who cannot join
- The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism).
- Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation)
- Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
- Unable to walk without a walking aid (e.g. cane, stick, walker)
Trial locations and contacts
1 site in 1 country.
United States1 site
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
About this study
Official title: The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.
Read the detailed description
This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation.
The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Being tested
- skin surface vibration, light skin surface vibration- SHAM
- Keywords
- Parkinson Disease, Essential tremor, Dystonia, Vibrotactile stimulation
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin surface vibrationOther
This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.
light skin surface vibration- SHAMOther
This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Continuous stimulation | Experimental | Continuous stimulation Receives: Other: skin surface vibration |
| Vibrotactile Intermittent stimulation | Experimental | Intermittent stimulation Receives: Other: skin surface vibration |
| Vibrotactile Sham | Sham comparator | Sham stimulation Receives: Other: light skin surface vibration- SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Tremor Assessment
An external accelerometer will be adhered to the skin of the dorsum of the hand and will be used to quantify displacement of the hand due to tremor in the following conditions:
- 1. Sitting at rest
- 2. Sitting with both arms outstretched
- 3. Sitting at rest while performing a distracting cognitive task
- 4. Transition from rest to posture (arms held directly in front of patient) for 10 seconds
Measured: Baseline up to immediately after the sham intervention
Secondary outcomes (3)
Functional Dexterity Task (FDT)
Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
Measured: Baseline up to immediately after the sham intervention
Reaction time task
Subjects will look at a central fixation symbol on computer screen and press a computer keyboard/mouse button when the GO signal appears. The time between the onset of the fixation cross and the green GO signal will vary so that the onset of the GO signal will not be predictable. The time between appearance of the GO signal and recorded keyboard response will be recorded as reaction time
Measured: Baseline up to immediately after the sham intervention
Timed-up-and-go (TUG) gait task
Subjects are asked to stand up from a chair, walk 3 meters to a horizontal line marked with red tape on the floor, turn around, walk back and sit down, at a comfortable pace. this task will be performed on an the instrumented mat that measures gait characteristics.
Measured: Baseline up to immediately after the sham intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start7 Oct 2021
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Sponsor
- Investigators
- Christopher W Hess, MD, Principal investigator, Norman Fixel Institute for Neurological Diseases, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106816
- Sponsor's protocol ID
- 202002167
- Status last verified
- Sep 2022
- First submitted
- 12 Oct 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published, but no PHI will be made available.
Publications
Charcot JM. Vibratory therapeutics.--The application of rapid and continuous vibrations to the treatment of certain diseases of the nervous system. 1892. J Nerv Ment Dis. 2011 Nov;199(11):821-7. doi: 10.1097/NMD.0b013e31823899bc. No abstract available.
PubMed 22048131Gassner H, Janzen A, Schwirtz A, Jansen P. Random Whole Body Vibration over 5 Weeks Leads to Effects Similar to Placebo: A Controlled Study in Parkinson's Disease. Parkinsons Dis. 2014;2014:386495. doi: 10.1155/2014/386495. Epub 2014 Oct 13.
PubMed 25371843Haas CT, Turbanski S, Kessler K, Schmidtbleicher D. The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. NeuroRehabilitation. 2006;21(1):29-36.
PubMed 16720935Jobges EM, Elek J, Rollnik JD, Dengler R, Wolf W. Vibratory proprioceptive stimulation affects Parkinsonian tremor. Parkinsonism Relat Disord. 2002 Jan;8(3):171-6. doi: 10.1016/s1353-8020(01)00016-5.
PubMed 12039427Kapur SS, Stebbins GT, Goetz CG. Vibration therapy for Parkinson's disease: Charcot's studies revisited. J Parkinsons Dis. 2012;2(1):23-7. doi: 10.3233/JPD-2012-12079.
PubMed 23939405
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
- ClinicalTrials.gov ID
- NCT05106816
- Acronym / sponsor ID
- 202002167
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Keywords
- Parkinson Disease, Essential tremor, Dystonia, Vibrotactile stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.
Detailed description
This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation.
The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Continuous stimulation | Experimental | Other: skin surface vibrationContinuous stimulation |
| Vibrotactile Intermittent stimulation | Experimental | Other: skin surface vibrationIntermittent stimulation |
| Vibrotactile Sham | Sham comparator | Other: light skin surface vibration- SHAMSham stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 and able to provide informed consent.
- Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist.
- Medically optimized without planned medication changes for the duration of the study.
- For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale.
- For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor
Key exclusion criteria (4 listed)
- The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism).
- Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation)
- Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
- Unable to walk without a walking aid (e.g. cane, stick, walker)
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 |
|---|---|---|
| skin surface vibrationThis study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. | Other | Vibrotactile Continuous stimulation, Vibrotactile Intermittent stimulation |
| light skin surface vibration- SHAMThis study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms. | Other | Vibrotactile Sham |
Primary outcome
Quantitative Tremor Assessment
Time frame: Baseline up to immediately after the sham intervention
An external accelerometer will be adhered to the skin of the dorsum of the hand and will be used to quantify displacement of the hand due to tremor in the following conditions: * 1. Sitting at rest * 2. Sitting with both arms outstretched * 3. Sitting at rest while performing a distracting cognitive task * 4. Transition from rest to posture (arms held directly in front of patient) for 10 seconds
3 secondary outcomes
Functional Dexterity Task (FDT)
Time frame: Baseline up to immediately after the sham intervention
Reaction time task
Time frame: Baseline up to immediately after the sham intervention
Timed-up-and-go (TUG) gait task
Time frame: Baseline up to immediately after the sham intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 22048131Charcot JM. Vibratory therapeutics.--The application of rapid and continuous vibrations to the treatment of certain diseases of the nervous system. 1892. J Nerv Ment Dis. 2011 Nov;199(11):821-7. doi: 10.1097/NMD.0b013e31823899bc. No abstract available.
- Background: PubMed 25371843Gassner H, Janzen A, Schwirtz A, Jansen P. Random Whole Body Vibration over 5 Weeks Leads to Effects Similar to Placebo: A Controlled Study in Parkinson's Disease. Parkinsons Dis. 2014;2014:386495. doi: 10.1155/2014/386495. Epub 2014 Oct 13.
- Background: PubMed 16720935Haas CT, Turbanski S, Kessler K, Schmidtbleicher D. The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. NeuroRehabilitation. 2006;21(1):29-36.
- Background: PubMed 12039427Jobges EM, Elek J, Rollnik JD, Dengler R, Wolf W. Vibratory proprioceptive stimulation affects Parkinsonian tremor. Parkinsonism Relat Disord. 2002 Jan;8(3):171-6. doi: 10.1016/s1353-8020(01)00016-5.
- Background: PubMed 23939405Kapur SS, Stebbins GT, Goetz CG. Vibration therapy for Parkinson's disease: Charcot's studies revisited. J Parkinsons Dis. 2012;2(1):23-7. doi: 10.3233/JPD-2012-12079.
- Individual participant dataSharing planned: No. Data will be published, but no PHI will be made available.
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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.
Christopher W Hess, MD principal investigator
Norman Fixel Institute for Neurological Diseases, University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin surface vibration in people with Parkinson Disease and Essential Tremor, run by University of Florida 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 5 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: finished, as of the sponsor's last update on 27 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantitative Tremor Assessment (time frame: Baseline up to immediately after the sham intervention). 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 NCT05106816, which also lists 5 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 27 Sep 2022.