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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06036368
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Stimvia s.r.o.

Tracking Information
First Submitted Date  ICMJE August 18, 2023
First Posted Date  ICMJE September 13, 2023
Last Update Posted Date September 13, 2023
Estimated Study Start Date  ICMJE September 15, 2023
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2023)
Safety and tolerability [ Time Frame: Baseline to end of treatment at 6 weeks ]
Incidence of treatment emergent adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2023)
Efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 6, 2023)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    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)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)
  • Exploratory efficacy [ Time Frame: Baseline to end of treatment at 6 weeks ]
    Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Essential Tremor
Intervention  ICMJE Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve
Study Arms  ICMJE Experimental: Peroneal eTNM arm
All patients will receive treatment with peroneal eTNM
Intervention: Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2023)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roman V Dvorak, MD PhD +420 734 577 837 dvorak@stimvia.com
Contact: Lukas Doskocil +420 776 721 127 doskocil@stimvia.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06036368
Other Study ID Numbers  ICMJE TS004-PD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stimvia s.r.o.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stimvia s.r.o.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Skoloudik, MD, PhD Cerebrovaskulární poradna s.r.o., Ostrava
PRS Account Stimvia s.r.o.
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP