Parkinson DiseaseNCT06570421
24-months Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
A study testing Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) in people with Parkinson Disease and Essential Tremor, run by Stimvia s.r.o. at 1 site in Czechia.
Trial summary
This study investigates the long-term safety and tolerability of home peroneal eTNM® therapy using the URIS I™ device in subjects with Parkinson's disease (PD) or Essential Tremor (ET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- What is being tested?
- Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Jul 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Has completed participation in study TS004-PD
- Competent and willing to provide written, informed consent to participate in the study.
- Stable dose of any chronic medications, if applicable, for 30 days prior to study entry
- Willing to comply with study protocol requirements.
- Subject agrees not to participate in another study from 30 days prior the baseline visit until the final study visit.
- For subjects with PD:
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- Bradykinesia in "on" period based on clinical assessment
- Rigidity in "on" period based on clinical assessment
- Hand/arm exhibiting tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the MDS-UPDRS tremor score in "on" period
- For subjects with ET:
- Visible hand/arm and/or foot/leg tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the TETRAS
Who cannot join
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Presence of clinical signs or diagnosis of dementia
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Presence of clinical signs of peripheral neuropathy on lower limbs
- Presence of chorea and/or dyskinesia
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- Clinical symptoms or diagnosis of major depressive disorder
- Presence of any other neurodegenerative disease. These may include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Botulinum toxin injection within 6 months prior to study enrollment
- Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of <1% year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test in urine at Visits 1 needs to be negative in women of childbearing potential.
- Subjects unable to communicate effectively with the investigator and staff
- Life expectancy less than 6 months
- Subject with active malignant disease
- Subject who, in the opinion of the physician, may interfere with optimal participation in the clinical trial or may pose a risk to the subject
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Cerebrovaskulární poradna s.r.o.
Ostrava, 70200
David Skoloudik, MD, PhD, +420 739 782 970, skoloudik@email.cz
About this study
Official title: 24-months, Open-label, Single-Site Extension Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)
This study investigates the long-term safety and tolerability of home peroneal eTNM® therapy using the URIS I™ device in subjects with Parkinson's disease (PD) or Essential Tremor (ET). Previously, a 6-week open-label pilot study with 24 PD or ET patients demonstrated that home-based peroneal eTNM® is safe, well-tolerated, and has a high adherence rate of over 90%. No treatment-related adverse events were observed. Although the pilot study was not designed to prove efficacy, it suggested positive effects on tremor, with improvements sustained for weeks after treatment. This extension study aims to further evaluate the long-term safety, tolerability, and efficacy of peroneal eTNM® in PD and ET patients.
Read the detailed description
This is a study to investigate the long-term safety and tolerability of home peroneal eTNM® delivered by URIS I™ in subjects with PD or ET. The safety, tolerability and efficacy of the home-based peroneal eTNM® using URIS ITM neurostimulator in the treatment of symptoms related to movement disorders in subjects with PD and ET has been recently investigated in the study (NTC06036368). This 6-weeks, open-label, single-site pilot study enrolled 24 patients with either PD or ET and was completed in April 2024. This pilot study showed that home-based peroneal eTNM® was safe and well tolerated by patients. No adverse events related to treatment were observed during the study period. These data confirm the excellent safety profile of the peroneal eTNM® that has been observed in previous studies in the overactive bladder population. In addition, all patients were able to stimulate themselves at home without assistance. Adherence to the treatment was very high, reaching well over 90 %. Although this pilot study was not designed to demonstrate the efficacy of peroneal eTNM®, due to its pilot nature and the small sample size, the observed results suggest noteworthy positive effects on rest, postural and kinetic tremor as measured visually, by accelerometers and by validated MDS-UPDRS and TETRAS scales. Importantly, patients reported sustained improvement in tremor throughout the treatment and continuously for several weeks after conclusion of the 6 weeks stimulation period. Data obtained at EoS visit (6 weeks after the last stimulation) lend support for a long-lasting persistence of the effect. Based on these data, the present extension study is designed to evaluate the long-term safety, tolerability and efficacy of peroneal eTNM® in patients with PD and ET. The study will use the medical device URIS I™, which has been assessed for conformity and issued a declaration of conformity. This agent will be used for a different indication, or on a different group of patients, however, without any change in the procedure of use. The clinical trial will be conducted in accordance with clinical trial plan TS005.
- Conditions
- Parkinson Disease, Essential Tremor
- Being tested
- Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
- Keywords
- Parkinson Diseases (PD), Essential Tremor (ET), Peroneal Electrical Transcutaneous Neuromodulation, pETNM
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)Device
Also called URIS
This is a non-invasive intervention, which utilizes direct transcutaneous, electrical stimulation of the peroneal nerve
| Study group | Role | What they receive |
|---|---|---|
| Peroneal eTNM arm | Experimental | All patients will receive treatment with peroneal eTNM Receives: Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessed by Treatment Emergent Adverse Events
Safety and tolerability based on all safety data collected in the study, including number and type of treatment emergent adverse events (TRAEs).
Measured: Baseline to end of the treatment (24 months, based on the study protocol)
Secondary outcomes (1)
Therapy Response Measured by Patient Global Impression of Improvement (PGI-I) Scale
Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)
Measured: Baseline to end of the treatment (24 months, based on the study protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start19 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stimvia s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Skoloudik, MD, Ph.D., Principal investigator, Cerebrovaskularni poradna s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570421
- Sponsor's protocol ID
- TS005
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-months, Open-label, Single-Site Extension Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)
- ClinicalTrials.gov ID
- NCT06570421
- Acronym / sponsor ID
- TS005
- Conditions
- Parkinson Disease, Essential Tremor
- Keywords
- Parkinson Diseases (PD), Essential Tremor (ET), Peroneal Electrical Transcutaneous Neuromodulation, pETNM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stimvia s.r.o.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
This study investigates the long-term safety and tolerability of home peroneal eTNM® therapy using the URIS I™ device in subjects with Parkinson's disease (PD) or Essential Tremor (ET). Previously, a 6-week open-label pilot study with 24 PD or ET patients demonstrated that home-based peroneal eTNM® is safe, well-tolerated, and has a high adherence rate of over 90%. No treatment-related adverse events were observed. Although the pilot study was not designed to prove efficacy, it suggested positive effects on tremor, with improvements sustained for weeks after treatment. This extension study aims to further evaluate the long-term safety, tolerability, and efficacy of peroneal eTNM® in PD and ET patients.
Detailed description
This is a study to investigate the long-term safety and tolerability of home peroneal eTNM® delivered by URIS I™ in subjects with PD or ET. The safety, tolerability and efficacy of the home-based peroneal eTNM® using URIS ITM neurostimulator in the treatment of symptoms related to movement disorders in subjects with PD and ET has been recently investigated in the study (NTC06036368). This 6-weeks, open-label, single-site pilot study enrolled 24 patients with either PD or ET and was completed in April 2024. This pilot study showed that home-based peroneal eTNM® was safe and well tolerated by patients. No adverse events related to treatment were observed during the study period. These data confirm the excellent safety profile of the peroneal eTNM® that has been observed in previous studies in the overactive bladder population. In addition, all patients were able to stimulate themselves at home without assistance. Adherence to the treatment was very high, reaching well over 90 %. Although this pilot study was not designed to demonstrate the efficacy of peroneal eTNM®, due to its pilot nature and the small sample size, the observed results suggest noteworthy positive effects on rest, postural and kinetic tremor as measured visually, by accelerometers and by validated MDS-UPDRS and TETRAS scales. Importantly, patients reported sustained improvement in tremor throughout the treatment and continuously for several weeks after conclusion of the 6 weeks stimulation period. Data obtained at EoS visit (6 weeks after the last stimulation) lend support for a long-lasting persistence of the effect. Based on these data, the present extension study is designed to evaluate the long-term safety, tolerability and efficacy of peroneal eTNM® in patients with PD and ET. The study will use the medical device URIS I™, which has been assessed for conformity and issued a declaration of conformity. This agent will be used for a different indication, or on a different group of patients, however, without any change in the procedure of use. The clinical trial will be conducted in accordance with clinical trial plan TS005.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peroneal eTNM arm | Experimental | Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)All patients will receive treatment with peroneal eTNM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has completed participation in study TS004-PD
- Competent and willing to provide written, informed consent to participate in the study.
- Stable dose of any chronic medications, if applicable, for 30 days prior to study entry
- Willing to comply with study protocol requirements.
- Subject agrees not to participate in another study from 30 days prior the baseline visit until the final study visit.
Key exclusion criteria (15 listed)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Presence of clinical signs or diagnosis of dementia
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Presence of clinical signs of peripheral neuropathy on lower limbs
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 |
|---|---|---|
| Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)Also: URISThis is a non-invasive intervention, which utilizes direct transcutaneous, electrical stimulation of the peroneal nerve | Device | Peroneal eTNM arm |
Primary outcome
Safety and Tolerability Assessed by Treatment Emergent Adverse Events
Time frame: Baseline to end of the treatment (24 months, based on the study protocol)
Safety and tolerability based on all safety data collected in the study, including number and type of treatment emergent adverse events (TRAEs).
1 secondary outcome
Therapy Response Measured by Patient Global Impression of Improvement (PGI-I) Scale
Time frame: Baseline to end of the treatment (24 months, based on the study protocol)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- 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.
David Skoloudik, MD, Ph.D. principal investigator
Cerebrovaskularni poradna s.r.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) in people with Parkinson Disease and Essential Tremor, run by Stimvia s.r.o. at 1 site in Czechia.
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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Peter, Ph.D. (+420732745185, peter@stimvia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Assessed by Treatment Emergent Adverse Events (time frame: Baseline to end of the treatment (24 months, based on the study protocol)). 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 26 Aug 2024.