Parkinson's DiseaseNCT02134795
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
A study testing TNM Device in people with Parkinson's Disease, run by Scion NeuroStim at 1 site in United States.
Trial summary
This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients. 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?
- TNM Device
- 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 2014to Sep 2014
- 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
- Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
- Patient should have a Hoehn \& Yahr staging of 1 to 3 (mild to moderate)
- Patient must be an adult (18 years of age or older)
Who cannot join
- Women who are pregnant or nursing
- have a history of significant cardiovascular disease (no pacemakers)
- have a history of unstable mood disorder or unstable anxiety disorder or psychosis
- use a hearing aid
- have a cochlear implant
- have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.
Show all 11Show fewer
- have a diagnosed vestibular dysfunction
- abuse alcohol or other drugs
- have had eye surgery within the previous three months or ear surgery within the previous six months
- have active ear infections or a perforated tympanic membrane
- have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.
- Conditions
- Parkinson's Disease
- Being tested
- TNM Device
- Keywords
- Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM DeviceDevice
The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit. Receives: Device: TNM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)
A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test.
Measured: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: The study aimed to enroll 10 patients but only enrolled 6 total. Instead of keeping the study open, it was terminated early with incomplete results.
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's 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134795
- Sponsor's protocol ID
- Pro00053320
- Status last verified
- Apr 2025
- First submitted
- 6 May 2014
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02134795
- Acronym / sponsor ID
- Pro00053320
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study aimed to enroll 10 patients but only enrolled 6 total. Instead of keeping the study open, it was terminated early with incomplete results.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Device: TNM DeviceMild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
- Patient should have a Hoehn \& Yahr staging of 1 to 3 (mild to moderate)
- Patient must be an adult (18 years of age or older)
Key exclusion criteria (11 listed)
- Women who are pregnant or nursing
- have a history of significant cardiovascular disease (no pacemakers)
- have a history of unstable mood disorder or unstable anxiety disorder or psychosis
- use a hearing aid
- have a cochlear implant
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 |
|---|---|---|
| TNM DeviceThe noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes. | Device | Caloric Vestibular Stimulation (CVS) |
Primary outcome
Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)
Time frame: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline
A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study testing TNM Device in people with Parkinson's Disease, run by Scion NeuroStim 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 11 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: stopped early, as of the sponsor's last update on 2 May 2025. 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 2 May 2025). 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?
Motor UPDRS Score (Unified Parkinson's Disease Rating Scale) (time frame: Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline). 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 2 May 2025.