Closed-Loop Electronic stimulation - Mechanomyogram sensor system for Passive tremor Suppression treatment (CLEMPTS)

St George’s University Hospitals NHS Foundation Trust0 sites20 target enrollmentApril 14, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 14, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

St George’s University Hospitals NHS Foundation Trust

•1\. Adults aged over 18 years
•2\. Diagnosed with essential tremor or Parkinson's related tremor by a neurologist with expertise in movement disorders
•3\. Functional disability due to tremor reported by patient or clinician
•4\. Willing and able to give informed consent

•1\. Cognitive impairment (judged by the clinician on the care team or in the research team as a participant not having sufficient mental capacity to understand the study and its requirements). This includes anyone who, in the opinion of clinicians on the care team or clinicians in the research team, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
•2\. Subject has a severe medical or psychiatric illness that would interfere with completing initial and follow\-up assessments
•3\. Participation in concurrent research which involves a novel therapeutic IMP or device
•4\. Although the device is not expected to interfere with pregnancy, women who are pregnant would not be eligible to take part
•5\. Active treatment with an implantable stimulation device (such as a cardiac pacemaker or deep brain stimulation implantable programmable generator)
•6\. Allergies to neoprene, mylar, electrode hydrogel or medical tape