Parkinson's DiseaseNCT06036368
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's Disease and Essential Tremor, run by Stimvia s.r.o. at 1 site in Czechia.
Trial summary
This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parkinson's 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
- 23 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Sep 2023to 30 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- 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 screening visit until the final study visit
- For subjects with PD:
- 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
- Severe degree of disability or dependence in daily activities >grade 3 as measured by modified Rankin Scale (mRS)
- 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
Show all 18Show fewer
- Presence of chorea and/or dyskinesia
- 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
- Participation in another interventional clinical trial in the last 30 days, which may confound the results of this study, unless approved by the Sponsor
- 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 both Visits 1 and 2 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 with alcohol (more than 100 mg ethanol per day) or drug abuse during the recruitment and during the trial course
- 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.
About this study
Official title: 6-weeks, Open-label, Single-Site 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 is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.
Read the detailed description
This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.
- Conditions
- Parkinson's Disease, Essential Tremor
- Being tested
- Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
- Keywords
- Parkinson's Disease (PD) and Essential Tremor (ET), Peroneal Electrical Transcutaneous NeuroModulation
- 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
This is a non-invasive intervention, which utilizes direct trancutaneous, 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
Incidence of treatment emergent adverse events
Measured: Baseline to end of treatment at 6 weeks
Secondary outcomes (1)
Response of the condition on the therapy
Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)
Measured: Baseline to end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Sep 2023
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimvia s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Skoloudik, MD, PhD, Principal investigator, Cerebrovaskulární poradna s.r.o., Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036368
- Sponsor's protocol ID
- TS004-PD
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 21 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-weeks, Open-label, Single-Site 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
- NCT06036368
- Acronym / sponsor ID
- TS004-PD
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- Parkinson's Disease (PD) and Essential Tremor (ET), Peroneal Electrical Transcutaneous NeuroModulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stimvia s.r.o.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Sep 2023 (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 is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.
Detailed description
This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.
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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age
- 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 screening visit until the final study visit
Key exclusion criteria (18 listed)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Severe degree of disability or dependence in daily activities >grade 3 as measured by modified Rankin Scale (mRS)
- 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
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®)This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve | Device | Peroneal eTNM arm |
Primary outcome
Safety and tolerability
Time frame: Baseline to end of treatment at 6 weeks
Incidence of treatment emergent adverse events
1 secondary outcome
Response of the condition on the therapy
Time frame: Baseline to end of treatment at 6 weeks
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 21 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. This study is not recruiting at the moment.
David Skoloudik, MD, PhD principal investigator
Cerebrovaskulární poradna s.r.o., Ostrava
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's 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 8 inclusion and 18 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 21 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?
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?
Safety and tolerability (time frame: Baseline to end of treatment at 6 weeks). 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 21 Aug 2024.