Investigating a wrist-worn device to treat tremor with electrical stimulatio

Phase 2

• Conditions: Parkinson's disease-related tremor and essential tremor; Nervous System Diseases; Parkinson disease

• Registration Number: ISRCTN10416636
• Lead Sponsor: St George’s University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-14
• Last Update Posted: 8 April 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified