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Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor

Primary Purpose

Parkinson's Disease, Essential Tremor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Sponsored by
Stimvia s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease (PD) and Essential Tremor (ET), Peroneal Electrical Transcutaneous NeuroModulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Cerebrovaskulární poradna s.r.o.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peroneal eTNM arm

Arm Description

All patients will receive treatment with peroneal eTNM

Outcomes

Primary Outcome Measures

Safety and tolerability
Incidence of treatment emergent adverse events

Secondary Outcome Measures

Efficacy
Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)

Full Information

First Posted
August 18, 2023
Last Updated
September 6, 2023
Sponsor
Stimvia s.r.o.
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1. Study Identification

Unique Protocol Identification Number
NCT06036368
Brief Title
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stimvia s.r.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Essential Tremor
Keywords
Parkinson's Disease (PD) and Essential Tremor (ET), Peroneal Electrical Transcutaneous NeuroModulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peroneal eTNM arm
Arm Type
Experimental
Arm Description
All patients will receive treatment with peroneal eTNM
Intervention Type
Device
Intervention Name(s)
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Intervention Description
This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Incidence of treatment emergent adverse events
Time Frame
Baseline to end of treatment at 6 weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)
Time Frame
Baseline to end of treatment at 6 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory efficacy
Description
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)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)
Time Frame
Baseline to end of treatment at 6 weeks
Title
Exploratory efficacy
Description
Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)
Time Frame
Baseline to end of treatment at 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roman V Dvorak, MD PhD
Phone
+420 734 577 837
Email
dvorak@stimvia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas Doskocil
Phone
+420 776 721 127
Email
doskocil@stimvia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Skoloudik, MD, PhD
Organizational Affiliation
Cerebrovaskulární poradna s.r.o., Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cerebrovaskulární poradna s.r.o.
City
Ostrava
ZIP/Postal Code
70200
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Skoloudik, MD, PhD
Phone
+420 739 782 970
Email
skoloudik@email.cz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor

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