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SuspendedNCT06428526Updated Jul 14, 2026

Impact of Sensory Electrical Stimulation on Sensation and Tremor

An interventional study of Continuous stimulation strategy and Closed-loop stimulation strategy in Essential Tremor and Healthy Individuals, sponsored by Shirley Ryan AbilityLab. Suspended at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Basic science

Why this study was suspended
The study personnel left the institution and no alternative funding could be secured to implement the study
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Essential Tremor
  • Healthy Individuals

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Keywords

  • Essential Tremor
  • Proprioception
  • Fine motor control
  • Electrical nerve stimulation
03

In context

Essential Tremor

261 studies on the registry are indexed under Essential Tremor; 74 are open to participants now.

This study's planned enrollment of 40 is above the median of 24 across 185 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for Healthy Participants:

  • 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

Exclusion Criteria for Healthy Participants:

  • 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

Inclusion Criteria for ET Patients:

  • Age from 18 to 80 years, inclusive
  • 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) by a physician
  • At least moderate-severe tremor (based on the TETRAS Tremor Rating Scale) in an upper limb with pure flexion-extension wrist tremor during posture
  • Stable medication doses for at least 30 days prior to study enrollment and during entire study period
  • Able to understand and speak English

Exclusion Criteria for ET Patients:

  • History of significant head trauma (i.e., extended loss of consciousness, neurological damage)
  • Known structural brain lesion
  • Prior neurosurgical procedures
  • Mixed or complex 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 the 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Transcutaneous asES

    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

  • Experimental
    Percutaneous asES

    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

  • DeviceContinuous stimulation strategy

    Participants will be administered stimulation with a constant frequency stimulation.

  • DeviceClosed-loop stimulation strategy

    Participants will be administered with an activity-dependent stimulation.

06

What researchers measure

Primary outcomes

  1. Force perception via force matching tasks

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

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

  2. Position perception via position matching tasks

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

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. Tremor assessment using TETRAS

    The Essential Tremor Rating Assessment Scale (TETRAS) will be used to quantify tremor of the participants. The TETRAS scale ranges from 0 - 64. Higher scores mean worse tremor in the participant.

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

  2. Tremor assessment using arm kinematics

    Upper limb kinematics using inertial measurement units (IMUs) will be used to quantify tremor of the participants. IMUs will be placed on the hand, forearm, and upper arm of the participants.

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

07

Study locations

1 site
  • Shirley Ryan AbilityLab
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06428526
Lead sponsor
Shirley Ryan AbilityLab
Responsible party
Jose Pons (Principal Investigator, Shirley Ryan AbilityLab) — Principal investigator
First posted
May 24, 2024
Start date
Jan 24, 2025
Primary completion
Jul 15, 2026 (estimated)
Completion
Jul 15, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Jose L Pons, PhD
principal investigator · Shirley Ryan AbilityLab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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