Essential TremorNCT06428526
Impact of Sensory Electrical Stimulation on Sensation and Tremor
A study testing Continuous stimulation strategy and Closed-loop stimulation strategy in people with Essential Tremor and Healthy Individuals, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor, Healthy Individuals
- What is being tested?
- Continuous stimulation strategy and Closed-loop stimulation strategy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Able to understand and speak English
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Afferent-specific Peripheral Electrical Stimulation (asES) on Sensorimotor Control and Tremor
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.
- Conditions
- Essential Tremor, Healthy Individuals
- Being tested
- Continuous stimulation strategy, Closed-loop stimulation strategy
- Keywords
- Essential Tremor, Proprioception, Fine motor control, Electrical nerve stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous stimulation strategyDevice
Participants will be administered stimulation with a constant frequency stimulation.
Closed-loop stimulation strategyDevice
Participants will be administered with an activity-dependent stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Continuous stimulation strategy; Device: Closed-loop stimulation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force perception via force matching tasks
Force perception will be measured by evaluating the participant's ability to match a target force.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start24 Jan 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Why it stopped: The study personnel left the institution and no alternative funding could be secured to implement the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose L Pons, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428526
- Sponsor's protocol ID
- STU00217703
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Afferent-specific Peripheral Electrical Stimulation (asES) on Sensorimotor Control and Tremor
- ClinicalTrials.gov ID
- NCT06428526
- Acronym / sponsor ID
- STU00217703
- Conditions
- Essential Tremor, Healthy Individuals
- Keywords
- Essential Tremor, Proprioception, Fine motor control, Electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study personnel left the institution and no alternative funding could be secured to implement the study
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous asES | Experimental | Device: Continuous stimulation strategy, Device: Closed-loop stimulation strategyParticipants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist |
| Percutaneous asES | Experimental | Device: Continuous stimulation strategy, Device: Closed-loop stimulation strategyParticipants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous stimulation strategyParticipants will be administered stimulation with a constant frequency stimulation. | Device | Percutaneous asES, Transcutaneous asES |
| Closed-loop stimulation strategyParticipants will be administered with an activity-dependent stimulation. | Device | Percutaneous asES, Transcutaneous asES |
Primary outcome
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.
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.
2 secondary outcomes
Tremor assessment using TETRAS
Time frame: 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
Time frame: Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Pons, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous stimulation strategy and Closed-loop stimulation strategy in people with Essential Tremor and Healthy Individuals, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.