Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With… (NCT06036368) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Czechia23 participantsStarted 2023-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 diseas…
What they're measuring
1
Safety and tolerability
Timeframe: Baseline to end of treatment at 6 weeks