Viewing Study NCT06428526



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06428526
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-24
First Post: 2024-04-30

Brief Title: Impact of Sensory Electrical Stimulation on Sensation and Tremor
Sponsor: Shirley Ryan AbilityLab
Organization: Shirley Ryan AbilityLab

Study Overview

Official Title: Effects of Afferent-specific Peripheral Electrical Stimulation asES on Sensorimotor Control and Tremor
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to understand the acute short-term and long-term impact of transcutaneous andor percutaneous electrical stimulation with afferent-specific electrical stimulation asES on proprioception and fine motor control in the upper extremity For this purpose the researchers will use transcutaneous andor percutaneous asES high-density electromyography HD-EMG arm kinematic measurements and standardized clinical assessments This study will be conducted in healthy able-bodied individuals and patients with essential tremor ET
Detailed Description: The purpose of this study is to evaluate the impact of afferent-specific electrical stimulation asES delivered either transcutaneous or percutaneous electrodes on proprioception and fine motor control The researchers will study the effect of asES in force perception joint position perception and touch sensitivity as proxies for proprioception The researchers will also study the effect of asES on fine motor control by investigating the change in neural drive to the muscles before and after asES using the motor unit spike trains extracted from HD-EMG recordings Furthermore the researchers will also study the difference in effects of transcutaneous versus percutaneous asES on proprioception fine motor control and tremor in ET through HD-EMG and standard clinical measurements such as TETRAS and Perdue pegboard test These results will help the researchers understand the acute short-term and long-term effects of various methods of asES delivery transcutaneous or percutaneous and their impact on proprioception and fine motor control

Aim 1 Investigate the acute short-term and long-term effects of transcutaneous asES on proprioception and fine motor control The overall goal of this study is to provide insight into the effect of transcutaneous stimulation of la afferent pathways targeted to modulate spinal reflexes in patients with ET to reduce tremors which consequently might cause disruption in proprioception leading to changes in performance of fine motor control The researchers hypothesize that asES might disrupt proprioception causing decreased performance in fine motor control tasks in the acute during stimulation and short-term eg immediately following stimulation to 30 minutes post but the effects will diminish in the long-term up to 24 hours post stimulation time periods

Aim 2 Investigate the acute short-term and long-term effects of percutaneous asES on proprioception and fine motor control The goal of this aim is to evaluate the effects of percutaneous asES to modulate Ia afferents and spinal reflexes to result in tremor reduction in ET which consequently might cause disruption in proprioception leading to changes in performance of fine motor control The researchers hypothesize that percutaneous asES will disrupt proprioception and fine motor control but will also result in tremor reduction in the acute short-term and long-term periods

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None