Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury

November 2, 2026 updated by: Shepherd Center, Atlanta GA

Enhancing Motor Learning With Transcranial Electrical Stimulation for Upper Extremity Functional Restoration in People With Cervical Spinal Cord Injury

The goal of this pilot study is to find out how four different types of transcranial electrical stimulation (tES) affect brain activity, the process of acquiring new skills (also called motor learning), and hand function after cervical spinal cord injury (cSCI).

Participants will complete 5 study sessions: one sign-up session and four testing & intervention sessions. Total participation will take about 18 hours. During the sign-up session, researchers will: discuss study details, review the participant's health history to make sure that it is safe for them to participate, perform tests to ensure that the participant meets the study criteria, and collect the participant's demographic information. During each testing & intervention session, the participant will receive a different type of tES. Before and after getting tES, they will take part in tests that measure their brain activity and the strength, sensation, and function of their right hand.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Improved use of the upper extremities (UEs) is a paramount concern for most individuals with cervical spinal cord injury (cSCI). The majority of people with SCI have some remaining pathways connecting the cortical and spinal circuitry. Strengthening descending corticospinal circuits, which drive volitional control, has potential to have a significant impact on UE function. Therapeutic modalities that enhance descending drive via direct excitation of the cortical circuitry may be valuable adjuncts to neurorehabilitation training for people with SCI.

Transcranial electrical stimulation (tES) modulates cortical excitability via low intensity electrical stimulation applied to the scalp. It is an attractive candidate for use as an adjunct to standard neurorehabilitation training given its clinical accessibility; tES devices are cost effective, highly portable, require minimal training, and have short set-up times. Further, tES has been shown to improve implicit motor learning, a cornerstone of neurorehabilitation training. While the use of tES as a neuromodulatory intervention has been studied extensively in people with stroke, these modalities have received little attention in the realm of SCI neurorehabilitation research.

Multiple types of tES exist, including transcranial direct current stimulation (tDCS), transcranial pulsed current stimulation (tPCS), and transcranial random noise stimulation (tRNS). These modalities vary based on the applied waveform. Continuous, patterned, and variable waveforms are applied during tDCS, tPCS and tRNS, respectively. In addition to modulating cortical excitability, tDCS has been shown to improve implicit learning processes which are impaired after SCI. Preliminary evidence in neurologically intact individuals suggests that tPCS and tRNS may be more efficacious modulators of cortical excitability than tDCS. However, it is unknown whether these effects on cortical excitability carry over to improvements in implicit motor learning. Further, the type of tES that has the largest effect on motor learning and UE function in people with cSCI has yet to be determined. For this pilot project, the investigators will employ a sham-controlled, randomized crossover study designed to evaluate the comparative efficacy of four different types of tES (tDCS, tPCS, tRNS, and sham) in 12 participants with chronic cSCI via the following Specific Aims:

Aim 1. Quantify the effects of tDCS, tPCS, tRNS, and sham tES on implicit motor learning.

Aim 2. Quantify the effects of tDCS, tPCS, tRNS, and sham tES on UE function, strength and sensation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
        • Contact:
        • Principal Investigator:
          • Jennfer A Iddings, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cervical spinal cord injury (neurological level C1-C8) that occurred at least one year ago
  • International Standards for Neurological Classification of SCI/ASIA Impairment Scale (ISNCSCI/AIS) severity classification C or D
  • self-reported limitations in right hand function
  • volitional muscle activity in the right hand, as determined by a score ≥ 2 in at least one intrinsic hand muscle group evaluated in the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) strength subtest
  • ability to follow instructions
  • ability to communicate pain or discomfort
  • ability and willingness to consent to participate in the study and authorize use of protected health information

Exclusion Criteria:

  • spinal cord issues that are getting worse, such as degenerative or progressive vascular disorders of the spinal and/or spinal cord
  • metal implant in the head
  • history of uncontrolled seizures
  • history of frequent or severe headaches
  • damage to the nerves of the right arm/hand (lower motor neuron damage) as documented in the medical record, per participant report, or during in-person screening
  • prior tendon or nerve transfer surgery in the right arm/hand
  • severe pain, hypersensitivity, or contractures of the right arm/hand that would limit participation in arm and hand training
  • broken skin or wounds on your head/scalp where stimulation will be applied
  • if you're a woman, and you are pregnant, think you might be, or are actively trying to become pregnant
  • you have any other health issue that the lead investigators think could make it unsafe for you to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: transcranial electrical stimulation (tES) + functional task practice (FTP)

Participants will participate in a single session of each of the three tES types being evaluated combined with upper extremity FTP.
Other: transcranial direct current stimulation (tDCS) + FTP

tDCS (waveform: monophasic and continuous) will be delivered for a duration of 20 minutes and intensity of 2 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tDCS application and will consist primarily of task-oriented arm and hand activities.

Other: transcranial pulsed current stimulation (tPCS) + FTP

tPCS (waveform: monophasic square waves with 500 ms pulse duration and 50 ms inter-pulse interval) will be delivered for a duration of 20 minutes and intensity of 2 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tPCS application and will consist primarily of task-oriented arm and hand activities.

Other: transcranial random noise stimulation (tRNS) + FTP

tRNS (waveform: 0-500 Hz random frequency and Gaussian white noise random intensity) will be delivered for a duration of 20 minutes and intensity range of +/-1 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with tRNS application and will consist primarily of task-oriented arm and hand activities.
Active Comparator: sham transcranial electrical stimulation (tES) + functional task practice (FTP)

Participants will participate in a single session of sham tES combined with upper extremity FTP.
Other: sham transcranial electrical stimulation (tES) + FTP

Sham tES will be delivered for a duration of 20 minutes and intensity of 0 mA using two saline-soaked reusable sponge electrodes (35 cm2 each). The active electrode will be placed over the hand representation of the motor cortex controlling the right upper extremity (C3, 10-20 EEG system) and the reference electrode will be placed over the contralateral supraorbital area (FP2, 10-20 EEG system). The FTP component of intervention will occur concurrently with sham tESapplication and will consist primarily of task-oriented arm and hand activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in brain activity
Time Frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Electroencephalography (EEG) event-related potential (ERP) amplitude will be recorded in the left parietofrontal network during performance of a modified serial reaction time task (mSRTT).
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
Change in brain connectivity
Time Frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Electroencephalography (EEG) alpha band parietofrontal connectivity will be recorded under two conditions: 1) resting state and 2) during performance of a modified serial reaction time task (mSRTT).
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in upper extremity (UE) function
Time Frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Function will be measured in the right UE using the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) quantitative prehension subtest. Participants will complete four tasks: pouring water from a bottle to a cup, moving nine pegs from one side of a board to the other, inserting a key into a lock and rotating, and fastening four nuts onto screws. Each task will be scored on a 0-5 scale (0: task cannot be conducted at all - 5: task conducted without difficulty using the expected grasp pattern) and timed (maximum of 75 seconds will be allowed per task). The number of drops during each task will also be recorded. The total score, time and number of drops for all four tasks will then be calculated. The maximum score is 20 with higher scores denoting better UE function.
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
Change in upper extremity (UE) strength
Time Frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Strength will be measured in the right UE using key pinch force. The participant will be positioned with the shoulder in neutral, elbow flexed at approximately 90º, and forearm and wrist in neutral. Force will be quantified with an electronic pinchmeter positioned between the middle phalanx of the index finger and thumb pad. The participant will be given a command of "ready, set, go" upon which they will be instructed to pinch as hard as possible for 3 seconds. Three trials will be completed with a 60 second rest period between trials, and the mean force will be calculated.
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.
Change in upper extremity (UE) sensation
Time Frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Sensation will be measured in the right UE using the Graded Redefined Assessment of Strength Sensibility and Prehension version 2 (GRASSP v2) sensation subtest. Semmes-Weinstein monofilaments ranging in size from 3.61 to 6.65 will be used in three locations on the palmar surface of the hand while the participant's vision is occluded with a blindfold. The smallest monofilament (3.61) will be tested 3 times per location with 2/3 accurate responses indicating intact sensation. If the participant cannot detect the 3.61 filament at all locations, testing will continue with the next heaviest filament until the participant detects a filament at all three test locations or until testing with the heaviest filament is complete. In contrast to the 3.61 filament, the three other filaments will be tested once per location. The total score will be calculated by summing the scores for each test location. The maximum score is 12 with higher scores denoting better UE sensation.
Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shepherd Center, Atlanta GA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Georgia Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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