Sensory-specific Peripheral Stimulation for Tremor Management

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to understand the neurophysiological mechanisms of peripheral electrical stimulation (PES) in modulating supraspinal tremorogenic input to motoneurons. For this purpose, the investigators will use transcutaneous PES, high-density electromyography (HD-EMG), transcranial magnetic stimulation (TMS), electroencephalography (EEG), magnetic resonance imaging (MRI), and neuromusculoskeletal modelling. This study will be carried out in both healthy participants and patients with essential tremor (ET) and Parkinson's disease (PD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Age from 18 to 80 years

• No history of a brain and/or skull lesion

• Normal hearing and (corrected) vision

• Able to understand and give informed consent

• No neurological disorders, no tremor

• Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis)

• Able to understand and speak English

• Age from 18 to 80 years

• No prior history of skull lesions or craniotomy

• Normal hearing and (corrected) vision

• Able to understand and give informed consent

• Diagnosis of ET (Tremor Research investigation Group criteria) or diagnosis of PD (UK PD Society Brain bank diagnostic criteria) by a physician

• Tremor in at least an upper limb with pure flexion-extension wrist tremor with posture (ET) and rest (PD).

• Tremor at least moderate-severe by clinician judgment and tremor scales (Fahn Tolosa Marin Tremor Rating Scale (TETRAS), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS))

• Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, moderate to severe dyskinesias in PD)

• Stable medication doses for at least 30 days prior to study enrollment

• Able to understand and speak English

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Jose Pons, Ph.D
jpons@sralab.org
312-238-4549
Backup
Grace Hoo, BS
ghoo@sralab.org
312-238-4548
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 180
Treatments
Experimental: Healthy Participants
Healthy participants without motor disorders and medications influencing brain functions will be scanned with MRI and undergo PES and/or single pulse TMS during several visits, each with different stimulation patterns, while HD-EMG is recorded.
Experimental: Patients
Participants with Parkinson's Disease or essential tremor will be scanned with MRI and undergo PES and/or single pulse TMS during several visits, each with different stimulation patterns, while HD-EMG and EEG are recorded.
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: Northwestern University

This content was sourced from clinicaltrials.gov

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