Parkinson DiseaseSTEM-PDNCT04797611
STEM-Parkinson's Disease
A study testing TNM Device in people with Parkinson Disease and Parkinson's Disease and Parkinsonism, run by Scion NeuroStim at 23 sites in 2 countries.
Trial summary
This is a double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease and Parkinsonism
- What is being tested?
- TNM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 19 May 2022to 6 Dec 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants (aged 18 - 85 years inclusive)
- Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria (allowing for an exclusion in Step 2 for "more than one affected relative").
- Demonstrates a sustained, positive response to dopamine replacement therapies (DRTs) (e.g., levodopa, dopamine agonists or monoamine oxidase inhibitors) defined as either good or excellent responses (50-100%) for at least one year or moderate responses (30-49)% for at least three years prior to screen.
- Participant-reported or clinician-investigator-determined limitation, based on knowledge of medical history, to one or more activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
- Able and willing to consent to participate in the study.
- Willing and able to comply with study requirements.
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- Participants and investigators must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat motor or non-motor symptoms associated with PD during the study.
- Have at minimum a moderate burden of non-motor symptoms associated with Parkinson's disease (i.e., MDS-UPDRS part Ia and part Ib summed total score ≥ 9) at study screen to avoid floor effects for the primary endpoint (MDS-NMS).
- The principal investigator or designee must have confidence in the participant's ability to reliably use the TNM™ device, understand the assessments (provided in English only) and to complete the assessment battery within a given on-state period.
- Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial.
- Have capabilities to use and access smartphones and or tablets for the collection of some study data and/or tablets or computers for access to telemedicine platforms.
- Must be willing to answer questions related to sexual interest, arousal, and performance in an interview with study staff.
Who cannot join
- Participant anticipates being unable to attend all visits and complete all study activities.
- Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study trial. Women of child-bearing potential , who are not abstinent or exclusively in same sex relationships must:
- Test negative for pregnancy as indicated by a negative urine pregnancy test
- Agree to use an approved contraception method for the entirety of the trial
- Have a history or prior diagnosis of dementia or or adjusted score ≤ 20 on the Montreal Cognitive Assessment (MoCA) at the screening visit
- Have experienced a myocardial infarction, angina, or stroke within the past 12 months, or a transient ischemic attack within the past 6 months.
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- Are receiving deep brain stimulation therapy.
- Are treated with a pump for continuous delivery of dopamine replacement medication.
- Have received MRI guided high intensity focused ultrasound within the past 12 months.
- Experience frequent falls. (defined as 2 or more falls in the past month related to Parkinson's disease). Parkinson's falls are defined as falls associated with bradykinesia, freezing, turning, change in posture and postural dizziness and do not include accidental falls.
- Work night shifts
- Use a hearing aid that is implanted or that cannot be easily removed and replaced.
- Has any significant co-morbidity or illness which in the opinion of the investigator would prevent safe participation in the study, compliance with protocol requirements or which presents with symptoms that are also common in PD.
- Demonstrate suicidality at screening (scores ≥ 4 on the C-SSRS Baseline in section "Suicidal Ideation" (In the past Month)). Participants that respond affirmatively to question 4 or 5 (In the past Month) should receive a referral for mental health counseling according to local site regulations and standards
- Use a hearing aid that is implanted or that cannot be easily removed and replaced
- Have a cochlear implant or myringotomy tubes
- Have chronic that has been ongoing for at least 3 months and causes significant impairment of communication and/or impairment of activities of daily living.
- Have previously been diagnosed with traumatic brain injury with ongoing sequalae.
- Have been diagnosed with a co-morbid neurological disorder that may present with symptoms overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or aneurysm)
- Have been previously diagnosed with either clinically meaningful central vestibular dysfunction (lifetime) or have experienced clinically meaningful peripheral vestibular dysfunction within the last 12 months. For this purpose, clinically meaningful is defined as vestibular dysfunction which causes at least a minimal impairment in the individual activities of daily living (e.g., dressing, bathing, preparing food, conducting household chores, work or recreational activities).
- In the Investigator's opinion, currently abuse alcohol, abuse drugs (including legal, illegal or prescribed drugs) or have a history of alcohol or drug dependency within the past 5 years or use any drugs excluded as noted in the Excluded Medications List
- Have unresolved complications from a previous surgical procedure at the baseline visits, such as swelling or persistent pain, that requires medical intervention.
- Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination performed by medically qualified Investigators.
- Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
- Are currently enrolled or have participated in another interventional clinical trial within the last 30 days.
- Have had eye surgery within the previous three months or ear surgery within the previous six months.
- Have planned surgery scheduled to occur during the study that requires sedation and/or would typically be followed with a prescription for pain management.
- Have had eye surgery within the previous three months or ear surgery within the previous six months.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
Quest Research
Farmington Hills, Michigan, 48334
Texas Movement Disorder Specialist
Georgetown, Texas, 78628
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Houston Methodist Neurological Institute
Houston, Texas, 77030
University of Kansas Medical Center - Parkinson's Disease Center
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Georgetown University
McLean, Virginia, 22101
Veracity Neuroscience
Memphis, Tennessee, 38157
Mount Sinai Hospital
New York, New York, 10029
Riverside Neurology Specialists
Newport News, Virginia, 23601
Headlands Research Orlando
Orlando, Florida, 32819
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Meridian Clinical Research
Raleigh, North Carolina, 27607
Movement Disorder Center of Arizona
Scottsdale, Arizona, 85258
Inland Northwest Research
Spokane, Washington, 99202
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SW9 8RR
About this study
Official title: Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)
This is a double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.
Read the detailed description
The double-blinded, controlled, randomized clinical trial (RCT) will be conducted at 15 centers, at minimum, in the United States and the United Kingdom with the majority of centers in the United States. Up to 184 participants will enter and will self-administer treatments twice daily in their home setting over a period of 12 weeks following a 4 week baseline period. Each participant will complete 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.
- Being tested
- TNM Device
- Keywords
- Randomized Controlled Trial (RCT), Medical Devices, Non-Motor Symptoms (NMS), Non-Invasive Brain Stimulation, tvCVS
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM DeviceDevice
Also called tvCVS
Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
| Study group | Role | What they receive |
|---|---|---|
| Active: Investigational Treatment 1 | Active comparator | Investigational treatment mode (stimulation pattern) 1 - twice daily, 19 minute, active waveform treatments Receives: Device: TNM Device |
| Passive: Investigational Treatment 2 | Sham comparator | Investigational treatment mode (stimulation pattern) 2 - twice daily, 19 minute, passive waveform treatments Receives: Device: TNM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score
The MDS-NMS is a 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ >51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains (depression, anxiety, apathy, psychosis, impulse control/related disorders, cognition, orthostatic hypotension, urinary, sexual, gastrointestinal, sleep/wakefulness, pain, and other). Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden. The higher the total score, the more progressed (i.e., worse) is the disease state.
The change/difference in scores between the baseline (average of Days 1 and 29) and end of study treatment (Day 113) are reported. A positive change in scores indicates worsening.
Measured: 3 months
Secondary outcomes (5)
Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II, and III Combined Score
The MDS-UPDRS evaluates motor (Parts 1 and III) and non-motor (Part II) experiences and complications of Parkinson's disease (PD) to characterizes the extent and burden of disease. Each question has five response options linked to accepted clinical terms: (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe)/evaluations and are divided across Part I (13 questions, 52 possible points), Part II (13 questions, 52 possible points), and Part III (33 questions based on 18 items, several with right, left or other body distribution scores, 132 possible points). The Combined Score is the sum of the points for all three Parts and ranges from 0 to 236. The higher the score, the more progressed (i.e., worse) is the disease state.
The change/difference in scores between the baseline and end of study treatment are reported. A positive change in scores indicates worsening. A negative change in scores indicates improvement.
Measured: 3 months
Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
The MDS-UPDRS Part II is a 13-item patient-reported assessment of motor aspects of experiences of daily living. Scores range between 0-52, with the higher score indicating greater impairment to activities of daily living.
The change/difference in scores between the baseline (average of Days 1 and 29) and end of study treatment (Day 113) are reported. The more negative the change score, the greater the improvement.
Measured: 3 months
Change From Baseline in the Clinical Global Impression-Improvement (CGI-I)
The Clinical Global Impression-Improvement (CGI-I) is a clinician outcome assessment used to assess the extent of clinically meaningful change that has occurred in the patient's illness at day 113 relative to a baseline state (assessed at day 29). Changes in all aspects of Parkinson's disease (e.g., motor symptoms, non-motor symptoms and complications of anti-Parkinsonian medications) are considered. A 0 corresponds to no change, higher magnitude positive values correspond to greater improvements, and higher magnitude negative scores correspond to increased worsening. Scores range from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1=minimally improved, 2=much improved, 3=very much improved).
Measured: 3 months
Change in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III
The MDS-UPDRS Part III is a 33-item assessment of motor function evaluated by a trained, blinded rater. Each item has five response options linked to accepted clinical terms (0/normal, 1/slight, 2/mild, 3/moderate, and 4/severe) for a total scoring range of 0-132. Higher scores indicate more severe motor symptoms.
The change/difference in scores between the baseline (average of Days 1 and 29) and end of study treatment (Day 113) are reported. A positive change in scores indicates worsening. A negative change in scores indicates improvement.
Measured: 3 months
Change From in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
The PDQ-39 is a 39-item patient reported outcome questionnaire, which assesses Parkinson's disease-specific health related quality over the previous month. It includes 39 questions covering 8 dimensions: mobility (10), activities of daily living (6), emotional well-being (6), stigma (4), social support (3), cognition (4), communication (3), and bodily discomfort (3). Answers range from 0/never to 4/always. Each dimension is scored by summing the scores of each item, dividing that maximum possible score of all items in the dimension, and then multiplying by 100. The overall questionnaire score (the SI score) is the sum of all dimension scores divided by 8. Lower scores reflect better QoL.
The change/difference in scores between the baseline (Days 1 and 29 average) and end of study treatment (Day 113) are reported. A positive change in scores indicates worsening. A negative change in scores indicates improvement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start19 May 2022
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
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.
- 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, Care provider, Investigator
- Enrolment
- 188 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
- NCT04797611
- Sponsor's protocol ID
- SNS-PD-002
- Acronym
- STEM-PD
- Status last verified
- May 2025
- First submitted
- 10 Mar 2021
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT04797611
- Acronym / sponsor ID
- STEM-PD / SNS-PD-002
- Keywords
- Randomized Controlled Trial (RCT), Medical Devices, Non-Motor Symptoms (NMS), Non-Invasive Brain Stimulation, tvCVS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 13 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 double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.
Detailed description
The double-blinded, controlled, randomized clinical trial (RCT) will be conducted at 15 centers, at minimum, in the United States and the United Kingdom with the majority of centers in the United States. Up to 184 participants will enter and will self-administer treatments twice daily in their home setting over a period of 12 weeks following a 4 week baseline period. Each participant will complete 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: Investigational Treatment 1 | Active comparator | Device: TNM DeviceInvestigational treatment mode (stimulation pattern) 1 - twice daily, 19 minute, active waveform treatments |
| Passive: Investigational Treatment 2 | Sham comparator | Device: TNM DeviceInvestigational treatment mode (stimulation pattern) 2 - twice daily, 19 minute, passive waveform treatments |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult participants (aged 18 - 85 years inclusive)
- Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria (allowing for an exclusion in Step 2 for "more than one affected relative").
- Demonstrates a sustained, positive response to dopamine replacement therapies (DRTs) (e.g., levodopa, dopamine agonists or monoamine oxidase inhibitors) defined as either good or excellent responses (50-100%) for at least one year or moderate responses (30-49)% for at least three years prior to screen.
- Participant-reported or clinician-investigator-determined limitation, based on knowledge of medical history, to one or more activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
- Able and willing to consent to participate in the study.
Key exclusion criteria (28 listed)
- Participant anticipates being unable to attend all visits and complete all study activities.
- Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study trial. Women of child-bearing potential , who are not abstinent or exclusively in same sex relationships must:
- Have a history or prior diagnosis of dementia or or adjusted score ≤ 20 on the Montreal Cognitive Assessment (MoCA) at the screening visit
- Have experienced a myocardial infarction, angina, or stroke within the past 12 months, or a transient ischemic attack within the past 6 months.
- Are receiving deep brain stimulation therapy.
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 DeviceAlso: tvCVSStudy participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. | Device | Active: Investigational Treatment 1, Passive: Investigational Treatment 2 |
Primary outcome
Change in The International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score
Time frame: 3 months
The MDS-NMS is a 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ >51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains (depression, anxiety, apathy, psychosis, impulse control/related disorders, cognition, orthostatic hypotension, urinary, sexual, gastrointestinal, sleep/wakefulness, pain, and other). Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden. The higher the total score, the more progressed (i.e., worse) is the disease state. The change/difference in scores between the baseline (average of Days 1 and 29) and end of study treatment (Day 113) are reported. A positive change in scores indicates worsening.
5 secondary outcomes
Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II, and III Combined Score
Time frame: 3 months
Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Time frame: 3 months
Change From Baseline in the Clinical Global Impression-Improvement (CGI-I)
Time frame: 3 months
Change in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III
Time frame: 3 months
Change From in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
23 sites in 2 countries: 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 Disease and Parkinson's Disease and Parkinsonism, run by Scion NeuroStim at 23 sites in 2 countries.
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 12 inclusion and 28 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 13 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 23 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 13 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?
Change in The International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score (time frame: 3 months). 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 13 May 2025.