Impact of Sensory Electrical Stimulation on Sensation and Tremor

NCT06428526 | Active Not Recruiting

• 1 other identifier: STU00217703
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Essential Tremor; Healthy Individuals

Keywords

Essential Tremor; Proprioception; Fine motor control; Electrical nerve stimulation

Outcome Measures

Primary Outcomes (4)

• Force perception via force matching tasks

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

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

• Position perception via position matching tasks

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

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

• Touch perception using Semmes Weinstein monofilament testing

  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.

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

• Fine motor control as assessed by visuomotor tracking performance

  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.

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

Secondary Outcomes (2)

• Tremor assessment using TETRAS

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

• 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

Study Arms (2)

Transcutaneous asES

EXPERIMENTAL

Participants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist

Device: Continuous stimulation strategy; Device: Closed-loop stimulation strategy

Percutaneous asES

EXPERIMENTAL

Participants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist

Device: Continuous stimulation strategy; Device: Closed-loop stimulation strategy

Interventions

Continuous stimulation strategy DEVICE

Participants will be administered stimulation with a constant frequency stimulation.

Percutaneous asES; Transcutaneous asES

Closed-loop stimulation strategy DEVICE

Participants will be administered with an activity-dependent stimulation.

Percutaneous asES; Transcutaneous asES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 80 years, inclusive
• 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
• Able to understand and speak English

You may not qualify if:

• History of significant head trauma (i.e., extended loss of consciousness, neurological damage)
• Known structural brain lesion
• Prior neurosurgical procedures
• Tremors (as determined by study team)
• Co-existence of other neurological diseases
• Parkinsonism
• Medical (e.g., cardiological, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
• Pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, etc.)
• Inability to perform study tasks or assessments (e.g., follow instructions to stay still during asES procedures) or unable/unwilling to complete study forms
• Non-prescribed drug use or recreational marijuana use
• History of current substance abuse (exception: current nicotine use is allowed)
• Pregnancy
• Prisoners
• Age from 18 to 80 years, inclusive
• No prior history of skull lesions or craniotomy

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 24, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)