PARKINSON DISEASE (Disorder)Early Phase 1NCT07687732
Vibrotactile Stimulation for Parkinson's Disease
A Early Phase 1 study testing Vibrotactile stimulation in people with PARKINSON DISEASE (Disorder), run by University of Colorado, Denver at 1 site in United States.
Trial summary
Investigation on whether and how vibrotactile stimulation applied on the fingertips affects beta power in the subthalamic nucleus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 16 Aug 2025
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The population to be enrolled will be between 18 and 85 years of
- Have a diagnosis of idiopathic Parkinson's disease, determined by a movement disorders neurologist at the CU Movement Disorders Center
- Has undergone deep brain stimulation surgery at the University of Colorado hospital
Who cannot join
- have severe sensory abnormalities of the fingertips such as vibratory urticaria
- Patients that cannot clearly communicate with staff and speak English
- Patients that are on psychoactive or narcoleptic medications, medications that affect brain function or alter EEG recorded activity (i.e., anticonvulsants, ADHD, depression, or anxiety medication)
- Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC Space, Health Sciences Building
Denver, Colorado, 80045
About this study
Investigation on whether and how vibrotactile stimulation applied on the fingertips affects beta power in the subthalamic nucleus.
Read the detailed description
With a randomized order, two stimulation patterns are applied for one hour each on the fingertips of Parkinson's patients with deep brain stimulation, while periodically recording from subthalamic nucleus (STN) local field potentials (LFPs). The randomized vibrotactile stimulation (RVS) power is expected to reduce neuronal synchronization and LFP beta power. The All-on stimulation pattern is not expected to reduce neuronal synchronization and LFP beta power.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Vibrotactile stimulation
- Keywords
- Parkinson's disease, non-invasive stimulation, 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
Vibration patterns applied on the fingertips.
| Study group | Role | What they receive |
|---|---|---|
| RVS and All-on sequence | Experimental | Participants receives the RVS stimulation pattern followed by the All-on pattern Receives: Device: Vibrotactile stimulation |
| All-on and RVS sequence | Experimental | Participants receives the All-on stimulation pattern followed by the RVS pattern Receives: Device: Vibrotactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta band power
13-30 Hz frequency band
Measured: At baseline (pre-intervention) and after 30 min of intervention
Secondary outcomes (1)
MDS-UPDRS Part III
Movement disorder assessment for Parkinson's disease motor symptoms of the upper extremity. The scale is from 0 to 4 for the items in the MDS-UPDRS Part III, where 0 represents normal function (and 4 is worse).
Measured: At baseline (pre-intervention) and 1-hour of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start23 Aug 2023
- Primary completion12 Aug 2025
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687732
- Sponsor's protocol ID
- 22-1855
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be shared on github.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07687732
- Acronym / sponsor ID
- 22-1855
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson's disease, non-invasive stimulation, vibrotactile stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 7 Jul 2026 (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.
Investigation on whether and how vibrotactile stimulation applied on the fingertips affects beta power in the subthalamic nucleus.
Detailed description
With a randomized order, two stimulation patterns are applied for one hour each on the fingertips of Parkinson's patients with deep brain stimulation, while periodically recording from subthalamic nucleus (STN) local field potentials (LFPs). The randomized vibrotactile stimulation (RVS) power is expected to reduce neuronal synchronization and LFP beta power. The All-on stimulation pattern is not expected to reduce neuronal synchronization and LFP beta power.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVS and All-on sequence | Experimental | Device: Vibrotactile stimulationParticipants receives the RVS stimulation pattern followed by the All-on pattern |
| All-on and RVS sequence | Experimental | Device: Vibrotactile stimulationParticipants receives the All-on stimulation pattern followed by the RVS pattern |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The population to be enrolled will be between 18 and 85 years of
- Have a diagnosis of idiopathic Parkinson's disease, determined by a movement disorders neurologist at the CU Movement Disorders Center
- Has undergone deep brain stimulation surgery at the University of Colorado hospital
Key exclusion criteria (4 listed)
- have severe sensory abnormalities of the fingertips such as vibratory urticaria
- Patients that cannot clearly communicate with staff and speak English
- Patients that are on psychoactive or narcoleptic medications, medications that affect brain function or alter EEG recorded activity (i.e., anticonvulsants, ADHD, depression, or anxiety medication)
- Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
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 stimulationVibration patterns applied on the fingertips. | Device | All-on and RVS sequence, RVS and All-on sequence |
Primary outcome
Beta band power
Time frame: At baseline (pre-intervention) and after 30 min of intervention
13-30 Hz frequency band
1 secondary outcome
MDS-UPDRS Part III
Time frame: At baseline (pre-intervention) and 1-hour of 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 7 Jul 2026.
- Individual participant dataSharing planned: Yes. All de-identified data will be shared on github.
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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 Early Phase 1 study testing Vibrotactile stimulation in people with PARKINSON DISEASE (Disorder), run by University of Colorado, Denver 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 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 7 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Beta band power (time frame: At baseline (pre-intervention) and after 30 min of intervention). 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 7 Jul 2026.