Parkinson DiseaseNCT05152836
The Effect of Vibrotactile Stimulation on Parkinson's Tremor
A study testing Vibrotactile stimulation at tremor frequency, Vibrotactile stimulation at tremor frequency*1.5 and Vibrotactile stimulation at continuous stimulation in people with Parkinson Disease and Tremor, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
Trial summary
Tremor in Parkinson's disease is a common and highly burdensome symptom. Recent evidence shows that areas in the brain that are underlying Parkinson's tremor overlap with those that respond to somatosensory stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Tremor
- What is being tested?
- Vibrotactile stimulation at tremor frequency, Vibrotactile stimulation at tremor frequency*1.5 and Vibrotactile stimulation at continuous stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Nov 2021to 19 May 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
- 18-80 years old and able to provide informed consent
- Have a diagnosis of idiopathic PD made by a movement disorders specialist
- Medically optimized without planned medication changes for the duration of the study • Resting tremor subscore >/= 2 of the most-affected arm on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) item 2.10
- Postural tremor subscore >/= 1 of the most-affected arm on the MDS-UPDRS item 3.15
- Signed informed consent
Who cannot join
- The presence of additional neurologic diseases that might confound testing or the coexistence of PD and essential tremor together (action tremor that was present prior to the development of parkinsonism)
- Moderate to severe peripheral neuropathy (reduced vibratory sensation) at the upper extremities, quantified with a graduated tuning fork
- Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
- Unable to walk without walking aid
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, 6500HB
About this study
Official title: The Effect of Vibrotractile Stimulation on Parkinson's Tremor - an Explorative Study
Tremor in Parkinson's disease is a common and highly burdensome symptom. Recent evidence shows that areas in the brain that are underlying Parkinson's tremor overlap with those that respond to somatosensory stimulation. Applying such stimulation to the tremulous limb might therefore influence tremor-related brain activity and thereby potentially reduce tremor. In this study, the investigators explore this possibility and investigate whether tremor specific vibrotactile stimulation at the wrist of the most affected arm influences tremor severity.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease, of which tremor is a common and highly burdensome symptom. The pathophysiology of tremor involves a cerebral network that consists of basal ganglia and a cerebello-thalamo-cortical motor circuit. Emerging evidence suggests that somatosensory input from the tremulous limb to the brain may influence this network. Specifically, tremor-related activity was observed in primary and secondary somatosensory cortex, and thalamic cells involved in tremor appear to be responsive to somatosensory stimulation as well. Somatosensory afferents may thus play a role in tremor pathophysiology and could therefore be used as treatment target. Here, the investigators will test this hypothesis by investigating the effect of modulating somatosensory input (with vibrotactile stimulation) on tremor severity.
The primary objectives are 1) to test whether rhythmic somatosensory input (vibrotactile stimulation) at tremor frequency reduces tremor power of Parkinson's tremor as compared to vibrotactile stimulation at 1.5 times tremor frequency and 2) whether continuous 80Hz vibrotactile stimulation reduces tremor power as compared to sham stimulation. As secondary objectives, the investigators will test whether the effect of vibrotactile stimulation on tremor power depends on the context in which tremor occurs (rest, cognitive coactivation, posture), whether stimulation at tremor frequency reduces tremor power as compared to sham stimulation, and whether vibrotactile stimulation has an effect on two other common PD symptoms: impaired gait and bradykinesia. The investigators will include 27 patients with Parkinson's disease and rest as well as postural tremor. The intervention involves subtle mechanical vibrations on the wrist or ankles. This is a non-invasive and painless way to provide somatosensory stimuli, in a continuous (80Hz) or rhythmic fashion (brief bursts of 80 Hz at tremor or step frequency).
The investigators expect that this study will provide mechanistic insights into if and how somatosensory (vibro-tactile) afferents influence the cerebral tremor circuit in Parkinson's disease, and may provide a solid basis for designing further clinical treatment studies.
- Conditions
- Parkinson Disease, Tremor
- Being tested
- Vibrotactile stimulation at tremor frequency, Vibrotactile stimulation at tremor frequency*1.5, Vibrotactile stimulation at continuous stimulation, Vibrotactile stimulation 10% below and above step frequency
- Keywords
- Parkinson disease, Vibrotactile stimulation, Tremor
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile stimulation at tremor frequencyDevice
Mechanical vibrations are applied at brief bursts of 80Hz that occur at the individual tremor frequency. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm.
Vibrotactile stimulation at tremor frequency*1.5Device
Mechanical vibrations are applied at 80Hz bursts at individual tremor frequency*1.5. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm.
Vibrotactile stimulation at continuous stimulationDevice
Continuous 80Hz stimulation is applied via a small device worn on the wrist of the most-affected arm.
Vibrotactile stimulation 10% below and above step frequencyDevice
This intervention is applied during assessment of gait. Two devices are worn on both ankles which allows alternating stimulation of both ankles with brief bursts of 80 HZ at the individual step frequency plus or minus 10%.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile stimulation atdifferent settings | Experimental | All participants receive vibrotactile stimulation at three different stimulation settings as well as one sham condition. Specifically, stimulation is applied at (1) brief bursts of 80Hz that occur at the individual tremor frequency, (2) 80Hz bursts at tremor frequency*1.5, and (3) continuous stimulation at 80Hz. The sham condition does not involve any stimulation. All of the stimulations will be applied under three different contextual manipulations: during rest, posture and cognitive coactivation (serial subtraction task). Within each context, stimulation/sham conditions are applied in random order. Receives: Device: Vibrotactile stimulation at tremor frequency; Device: Vibrotactile stimulation at tremor frequency*1.5; Device: Vibrotactile stimulation at continuous stimulation; Device: Vibrotactile stimulation 10% below and above step frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of vibrotactile stimulation at tremor frequency on tremor severity with active control
The investigators will investigate the effect of frequency specific stimulation compared to an active control condition, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (bursts at tremor frequency vs. bursts at 1.5 times tremor frequency).
Measured: 25 minutes
The effect of continuous vibrotactile stimulation on tremor severity
The investigators will investigate the effect of continuous stimulation compared to sham stimulation, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (continuous 80Hz stimulation vs. sham). For the two primary outcomes measures, Bonferroni correction will be applied to correct for multiple comparisons.
Measured: 25 minutes
Secondary outcomes (6)
The effect of vibrotactile stimulation at tremor frequency on tremor severity with passive control
The investigators will explore the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (bursts at tremor frequency vs. sham).
Measured: 25 minutes
The effect of continuous vibrotactile stimulation on bradykinesia
The average button presses per second in the keyboard finger tapping test during continuous 80Hz stimulation versus sham will be investigated.
Measured: 10 minutes
The effect of vibrotactile stimulation on gait
Time to complete the timed up and go task will be investigated, comparing stimulation 10% above step frequency/10% below step frequency/sham
Measured: 10 minutes
The effect of vibrotactile stimulation on freezing
Number of freezing episodes during the timed up and go task will be investigated, comparing stimulation 10% above step frequency/10% below step frequency/sham
Measured: 10 minutes
Investigating the effect of vibrotactile stimulation at tremor frequency on tremor severity in 3 different contexts
The investigators will explore the change in log transformed tremor power from baseline to stimulation as a function of stimulation setting (bursts at tremor frequency/bursts at 1.5 times tremor frequency) and context (rest/posture/cognitive coactivation).
Measured: 25 minutes
Investigating the effect of continuous stimulation on tremor severity in 3 different contexts
The investigators will explore the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (continuous 80Hz stimulation vs. sham) and context (rest/posture/cognitive coactivation).
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start30 Nov 2021
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Cognitive Neuroimaging
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Principal investigator, Franziska Goltz, Donders Centre for Cognitive Neuroimaging
- Investigators
- Rick C. Helmich, MD PhD, Principal investigator, Radboud University Nijmegen Medical Centre Donders Institute for Brain, Cognition and Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152836
- Sponsor's protocol ID
- NL77202.091.21
- Other IDs
- 2021-12968
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibrotractile Stimulation on Parkinson's Tremor - an Explorative Study
- ClinicalTrials.gov ID
- NCT05152836
- Acronym / sponsor ID
- NL77202.091.21
- Conditions
- Parkinson Disease, Tremor
- Keywords
- Parkinson disease, Vibrotactile stimulation, Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Donders Centre for Cognitive NeuroimagingUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 10 Dec 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.
Tremor in Parkinson's disease is a common and highly burdensome symptom. Recent evidence shows that areas in the brain that are underlying Parkinson's tremor overlap with those that respond to somatosensory stimulation. Applying such stimulation to the tremulous limb might therefore influence tremor-related brain activity and thereby potentially reduce tremor. In this study, the investigators explore this possibility and investigate whether tremor specific vibrotactile stimulation at the wrist of the most affected arm influences tremor severity.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease, of which tremor is a common and highly burdensome symptom. The pathophysiology of tremor involves a cerebral network that consists of basal ganglia and a cerebello-thalamo-cortical motor circuit. Emerging evidence suggests that somatosensory input from the tremulous limb to the brain may influence this network. Specifically, tremor-related activity was observed in primary and secondary somatosensory cortex, and thalamic cells involved in tremor appear to be responsive to somatosensory stimulation as well. Somatosensory afferents may thus play a role in tremor pathophysiology and could therefore be used as treatment target. Here, the investigators will test this hypothesis by investigating the effect of modulating somatosensory input (with vibrotactile stimulation) on tremor severity.
The primary objectives are 1) to test whether rhythmic somatosensory input (vibrotactile stimulation) at tremor frequency reduces tremor power of Parkinson's tremor as compared to vibrotactile stimulation at 1.5 times tremor frequency and 2) whether continuous 80Hz vibrotactile stimulation reduces tremor power as compared to sham stimulation. As secondary objectives, the investigators will test whether the effect of vibrotactile stimulation on tremor power depends on the context in which tremor occurs (rest, cognitive coactivation, posture), whether stimulation at tremor frequency reduces tremor power as compared to sham stimulation, and whether vibrotactile stimulation has an effect on two other common PD symptoms: impaired gait and bradykinesia. The investigators will include 27 patients with Parkinson's disease and rest as well as postural tremor. The intervention involves subtle mechanical vibrations on the wrist or ankles. This is a non-invasive and painless way to provide somatosensory stimuli, in a continuous (80Hz) or rhythmic fashion (brief bursts of 80 Hz at tremor or step frequency).
The investigators expect that this study will provide mechanistic insights into if and how somatosensory (vibro-tactile) afferents influence the cerebral tremor circuit in Parkinson's disease, and may provide a solid basis for designing further clinical treatment studies.
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 atdifferent settings | Experimental | Device: Vibrotactile stimulation at tremor frequency, Device: Vibrotactile stimulation at tremor frequency*1.5, Device: Vibrotactile stimulation at continuous stimulation, Device: Vibrotactile stimulation 10% below and above step frequencyAll participants receive vibrotactile stimulation at three different stimulation settings as well as one sham condition. Specifically, stimulation is applied at (1) brief bursts of 80Hz that occur at the individual tremor frequency, (2) 80Hz bursts at tremor frequency*1.5, and (3) continuous stimulation at 80Hz. The sham condition does not involve any stimulation. All of the stimulations will be applied under three different contextual manipulations: during rest, posture and cognitive coactivation (serial subtraction task). Within each context, stimulation/sham conditions are applied in random order. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years old and able to provide informed consent
- Have a diagnosis of idiopathic PD made by a movement disorders specialist
- Medically optimized without planned medication changes for the duration of the study • Resting tremor subscore >/= 2 of the most-affected arm on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) item 2.10
- Postural tremor subscore >/= 1 of the most-affected arm on the MDS-UPDRS item 3.15
- Signed informed consent
Key exclusion criteria (4 listed)
- The presence of additional neurologic diseases that might confound testing or the coexistence of PD and essential tremor together (action tremor that was present prior to the development of parkinsonism)
- Moderate to severe peripheral neuropathy (reduced vibratory sensation) at the upper extremities, quantified with a graduated tuning fork
- Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
- Unable to walk without walking aid
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 stimulation at tremor frequencyMechanical vibrations are applied at brief bursts of 80Hz that occur at the individual tremor frequency. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm. | Device | Vibrotactile stimulation atdifferent settings |
| Vibrotactile stimulation at tremor frequency*1.5Mechanical vibrations are applied at 80Hz bursts at individual tremor frequency*1.5. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm. | Device | Vibrotactile stimulation atdifferent settings |
| Vibrotactile stimulation at continuous stimulationContinuous 80Hz stimulation is applied via a small device worn on the wrist of the most-affected arm. | Device | Vibrotactile stimulation atdifferent settings |
| Vibrotactile stimulation 10% below and above step frequencyThis intervention is applied during assessment of gait. Two devices are worn on both ankles which allows alternating stimulation of both ankles with brief bursts of 80 HZ at the individual step frequency plus or minus 10%. | Device | Vibrotactile stimulation atdifferent settings |
Primary outcome
The effect of vibrotactile stimulation at tremor frequency on tremor severity with active control
Time frame: 25 minutes
The investigators will investigate the effect of frequency specific stimulation compared to an active control condition, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (bursts at tremor frequency vs. bursts at 1.5 times tremor frequency).
The effect of continuous vibrotactile stimulation on tremor severity
Time frame: 25 minutes
The investigators will investigate the effect of continuous stimulation compared to sham stimulation, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (continuous 80Hz stimulation vs. sham). For the two primary outcomes measures, Bonferroni correction will be applied to correct for multiple comparisons.
6 secondary outcomes
The effect of vibrotactile stimulation at tremor frequency on tremor severity with passive control
Time frame: 25 minutes
The effect of continuous vibrotactile stimulation on bradykinesia
Time frame: 10 minutes
The effect of vibrotactile stimulation on gait
Time frame: 10 minutes
The effect of vibrotactile stimulation on freezing
Time frame: 10 minutes
Investigating the effect of vibrotactile stimulation at tremor frequency on tremor severity in 3 different contexts
Time frame: 25 minutes
Investigating the effect of continuous stimulation on tremor severity in 3 different contexts
Time frame: 25 minutes
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 15 Feb 2023.
- 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.
Rick C. Helmich, MD PhD principal investigator
Radboud University Nijmegen Medical Centre Donders Institute for Brain, Cognition and Behavior
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 at tremor frequency, Vibrotactile stimulation at tremor frequency*1.5 and Vibrotactile stimulation at continuous stimulation in people with Parkinson Disease and Tremor, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
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 15 Feb 2023. 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 Netherlands. 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?
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?
The effect of vibrotactile stimulation at tremor frequency on tremor severity with active control (time frame: 25 minutes). The study lists 2 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 15 Feb 2023.