6090292
Last Update Posted: 2023-10-19
Recruiting
All Genders accepted | 18 Years-90 Years |
15 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Effects of Peripheral Electrical Stimulation With Focused Ultrasound on Motor Symptoms in Parkinson's Patients
Transcranial Ultrasound Stimulation (TUS) is an emerging non-invasive brain stimulation(NIBS) technique that can be used on both superficial and deep brain targets with a high spatial resolution as small as a few cubic millimeters. Functional Electrical stimulation is a peripheral stimulation technique researched and clinically used to restore motor function following conditions like stroke and Spinal cord injury. To date, there are no studies that have looked at the neuro modulatory effects of combining TUS and FES on motor symptoms in patients with Parkinson's disease. The current study aims to understand the neuromodulatory effects of combining tbFUS to bilateral primary motor cortex (M1) in Parkinsons's disease patients immediately followed by bilateral upper extremity FES of the hand muscles for improving motor symptoms.
There are 3 study visits and for all of them patients will remain in ON dopaminergic medication condition. Each visit will be a minimum of 7 days apart.
Each visit will contain 1 of 3 combinations:
Combination #1: Real TUS +Sham FES; Combination #2: Sham TUS+ Real FES; Combination #3: Real TUS +Real FES
Definition of:
Real TUS: The Real TUS paradigm will consist of 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz). The Power of Real tbFUS will be set at 20W.
Sham TUS: The Sham TUS paradigm will also consist of 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz), however the ultrasound head will be flipped so that the active side faces away from the head.
Real FES: Motor point stimulation (MPS) of the right and left hand and forearm (Muscles stimulated may include: Opponens Pollicis Brevis (OPB), Flexor Pollicis Brevis, Abductor Pollicis Brevis (APB), 1st Lumbrical, Flexor digitorum superficialis and the First Dorsal Interosseous (FDI)) muscles will be triggered in congruence with the voluntary effort of the Participant during execution of bilateral functional tasks involving the use of two and three finger pinch grip (e.g.: picking up and moving marbles, ball bearings etc.).
Sham FES: Motor point stimulation (MPS) of both right and left Biceps and Finger flexor muscles will be triggered in congruence with the voluntary effort of the participant during execution of bilateral functional tasks involving the use of two and three finger pinch grip (e.g.: picking up and moving marbles, ball bearings etc.).
Eligibility
Relevant conditions:
Parkinson Disease
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov