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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peroneal eTNM arm | Experimental | All patients will receive treatment with peroneal eTNM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) | Device | This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Incidence of treatment emergent adverse events | Baseline to end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response of the condition on the therapy | Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better) | Baseline to end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory efficacy | The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Skoloudik, MD, PhD | Cerebrovaskulárnà poradna s.r.o., Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerebrovaskulárnà poradna s.r.o. | Ostrava | 70200 | Czechia |
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Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better)) |
| Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better)) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better) | Baseline to end of treatment at 6 weeks |
| Exploratory efficacy | Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better) | Baseline to end of treatment at 6 weeks |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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