Parkinson's disease-related tremor and essential tremor Nervous System Diseases Parkinson disease
Conditions
Interventions
The trial is designed to determine whether the investigational device reduces tremor severity compared with sham electrical stimulation (ES) as measured by an accelerometer. The intervention has been
Sponsors
St George’s University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tremor severity measured by an accelerometer immediately before and after each of the 10 active or sham ES sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported acute tremor suppression (measured using the Patient Global Impression of Change scale) and clinician-rated reduction in upper limb tremor (measured using relevant sub-scores of Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (FTM) and clinician global impression of change scale) measured immediately before and after each of the 10 ES sessions 2. Induced neuroplasticity assessed using functional MRI or transcranial magnetic stimulation at baseline and at the end of the study 3. Side effects of stimulation and any adverse reactions recorded at any time during the study 4. Tremor measured with a wrist-worn wearable ambulatory monitor for 24 hours comparing before and after stimulation, measured before starting the intervention and at selected visits | — |
Countries
England, United Kingdom
Outcome results
None listed