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Clinical Trials/NCT06428526
NCT06428526
Active, not recruiting
Not Applicable

Effects of Afferent-specific Peripheral Electrical Stimulation (asES) on Sensorimotor Control and Tremor

Shirley Ryan AbilityLab1 site in 1 country40 target enrollmentJanuary 24, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Essential Tremor
Sponsor
Shirley Ryan AbilityLab
Enrollment
40
Locations
1
Primary Endpoint
Fine motor control as assessed by visuomotor tracking performance
Status
Active, not recruiting
Last Updated
11 months ago

Overview

Brief Summary

The purpose of this study is to understand the acute, short-term and long-term impact of transcutaneous and/or 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 and/or 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 (e.g., 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.

Registry
clinicaltrials.gov
Start Date
January 24, 2025
End Date
July 31, 2029
Last Updated
11 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Pons

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fine motor control as assessed by visuomotor tracking performance

Time Frame: Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit

Fine motor control at the wrist and hands will be measured by evaluating the performance of the participants in tracking various forms of trajectory by moving their wrist and hand in flexion-extension movements.

Force perception via force matching tasks

Time Frame: Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit

Force perception will be measured by evaluating the participant's ability to match a target force.

Position perception via position matching tasks

Time Frame: Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit

Position perception will be measured by evaluating the participant's ability to match a target joint position.

Touch perception using Semmes Weinstein monofilament testing

Time Frame: Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit

Touch perception will be assessed through Semmes-Weinstein monofilament testing. Roshen scores will be computed based on the filaments that are perceived by the participant. The range of Roschen scores can be from 0 -5. Higher scores mean better touch perception.

Secondary Outcomes

  • Tremor assessment using arm kinematics(Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit)
  • Tremor assessment using TETRAS(Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit)

Study Sites (1)

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