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Spinal Cord InjuryNCT07909317

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

A study testing transcranial direct current stimulation (tDCS) + FTP, transcranial pulsed current stimulation (tPCS) + FTP and transcranial random noise stimulation (tRNS) + FTP in people with Spinal Cord Injury, run by Shepherd Center, Atlanta GA at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury
What is being tested?
transcranial direct current stimulation (tDCS) + FTP, transcranial pulsed current stimulation (tPCS) + FTP and transcranial random noise stimulation (tRNS) + FTP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2026to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Shepherd Center

    Atlanta, Georgia, 30309

    Jennifer Iddings, PhD, 404-367-1239, jennifer.iddings@shepherd.org

    Jennfer A Iddings, PhD

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
transcranial direct current stimulation (tDCS) + FTP, transcranial pulsed current stimulation (tPCS) + FTP, transcranial random noise stimulation (tRNS) + FTP, sham transcranial electrical stimulation (tES) + FTP
Keywords
transcranial electrical stimulation, electroencephalography, motor learning, upper extremity function
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulation (tDCS) + FTPOther

    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.

  • transcranial pulsed current stimulation (tPCS) + FTPOther

    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.

  • transcranial random noise stimulation (tRNS) + FTPOther

    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.

  • sham transcranial electrical stimulation (tES) + FTPOther

    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.

Study groups in NCT07909317
Study groupRoleWhat they receive
transcranial electrical stimulation (tES) + functional task practice (FTP)ExperimentalParticipants will participate in a single session of each of the three tES types being evaluated combined with upper extremity FTP.
Receives: Other: transcranial direct current stimulation (tDCS) + FTP; Other: transcranial pulsed current stimulation (tPCS) + FTP; Other: transcranial random noise stimulation (tRNS) + FTP
sham transcranial electrical stimulation (tES) + functional task practice (FTP)Active comparatorParticipants will participate in a single session of sham tES combined with upper extremity FTP.
Receives: Other: sham transcranial electrical stimulation (tES) + FTP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in brain activity

    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).

    Measured: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

  2. Change in brain connectivity

    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).

    Measured: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Secondary outcomes (3)
  1. Change in upper extremity (UE) function

    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.

    Measured: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

  2. Change in upper extremity (UE) strength

    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.

    Measured: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

  3. Change in upper extremity (UE) sensation

    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.

    Measured: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909317
Sponsor's protocol ID
1123
Status last verified
Nov 2026
First submitted
20 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation (tDCS) + FTP, transcranial pulsed current stimulation (tPCS) + FTP and transcranial random noise stimulation (tRNS) + FTP in people with Spinal Cord Injury, run by Shepherd Center, Atlanta GA 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Nov 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain activity (time frame: Twice during each of the four testing & intervention sessions through study completion, an average of two weeks.). The study lists 2 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 5 Nov 2026.

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