Spinal Cord InjuryNCT06698224
Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI
A study testing Spinal cord transcutaneous stimulation and Paired spinal cord and peripheral nerve stimulation in people with Spinal Cord Injury and Spinal Cord Disease, run by Kessler Foundation at 1 site in United States.
Trial summary
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Spinal Cord Disease, Spinal Cord Injuries (SCI)
- What is being tested?
- Spinal cord transcutaneous stimulation and Paired spinal cord and peripheral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 1 Nov 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Non-progressive cervical SCI
- Greater than or equal to 6-months post spinal cord injury
- Stable medical condition
- Viable median and ulnar nerve as evident from MMR and M-Wave recordings
- Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.
- At least 18 years of age
Who cannot join
- Ventilator Dependent
- Untreated fracture or pressure ulcer
- Untreated psychiatric disorder or ongoing drug abuse
- Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
- Skeletal muscle Botox injections less than 6 months prior
- Previous tendon transfer of the arm or arms
Show all 23Show fewer
- Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
- Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- Unable or unwilling to wean from anti-spasticity medications
- History of seizure or epilepsy
- Metal in Head
- Cochlear implant
- Implanted brain stimulators
- Aneurysm clips
- Increased intracranial pressure (which lowers seizure threshold)
- Cardiac pacemaker
- Personal or family history of epilepsy
- Tricyclic antidepressants or neuroleptics (which lower seizure threshold)
- For healthy volunteer/participants:
- Neurological injury or disease
- Pregnant at the time of enrollment or planning to become pregnant during the course of the study
- Personal or family history of seizure or epilepsy
- Tricyclic antidepressants or neuroleptics (which lower seizure threshold)
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
Kessler Foundation
West Orange, New Jersey, 07052
Gail Forrest, Ph.D.
Susan Harkema, Ph.D.
About this study
Official title: Paired Spinal Cord and Peripheral Nerve Stimulation for Hand Function Recovery in Humans Post Cervical SCI
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.
Read the detailed description
Cervical spinal cord injury (SCI) results in paralysis and/or weakness of arms and hands that severely affects the independence and quality of life post-injury. Therefore, regaining arm and hand function remains the top priority of this population. Considering that SCI is mostly incomplete in nature, recent evidence suggests that physical or occupational therapy training combined with spinal cord transcutaneous stimulation (scTS) is effective in restoring arm and hand function post-cervical SCI. scTS is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord to facilitate motor function post-SCI. The beneficial effects of scTS can be further improved by coupling it with peripheral nerve stimulation (PNS), which supplies the arm and hand muscles.
This study aims to investigate how precisely timed paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) combined with physical therapy can improve the use of arms and hands in those with a SCI. Spinal cord transcutaneous stimulation (scTS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the spinal cord to excite the nervous system for the activity being trained and promote connections between the brain and spinal cord. Peripheral nerve stimulation (PNS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the arm, forearm, and hand to excite the peripheral nerves and promote connections between the spinal cord and the muscles involved in the activity-based recovery training. We hypothesize that precisely timed application of scTS and PNS will increase spinal cord excitability. Increased spinal cord excitability coupled with physical therapy will facilitate hand function recovery post-SCI.
Study aims:
- To establish optimal time sequencing for the paired scTS and PNS delivery resulting in the spinal cord motor neuron excitability in non-injured (NI) and SCI participants.
- To investigate the acute effects of paired scTS and PNS delivery on spinal cord motor neuron and corticospinal excitability.
- To investigate the effectiveness of paired scTS and PNS along with scTS combined with AB-UET in recovering hand function post cervical SCI.
- To identify the potential mechanisms of action underlying the observed changes in the hand function following training with paired scTS and PNS along with scTS combined with AB-UET.
This is a pretest-posttest experimental design. SCI participants will be enrolled for Aims 1, 2, 3 and 4. For SCI participants, On site medical evaluation, ASIA Impairment Scale (ISNCSCI-AIS), MVC grip strength and nerve intactness study will be collected or performed during the screening process. If the individual is potentially eligible for the study, as determined by the study physician and investigators, they will undergo pre-training assessments, 20 training sessions, and post-training assessments. Non-Injured (NI) participants will be enrolled for Aims 1 and 2.
- Being tested
- Spinal cord transcutaneous stimulation, Paired spinal cord and peripheral nerve stimulation
- Keywords
- Spinal cord injury, Hand function, Spinal cord stimulation, Paired stimulation, Physical therapy
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord transcutaneous stimulationDevice
Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.
Paired spinal cord and peripheral nerve stimulationDevice
Also called Spinal cord transcutaneous stimulation, Peripheral nerve stimulation
Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| scTS | Active comparator | This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy. Receives: Device: Spinal cord transcutaneous stimulation |
| scTS+PNS | Experimental | This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy. Receives: Device: Paired spinal cord and peripheral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRASSP
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a 3-part assessment designed to measure participant's hand and arm function. The test specifically measures strength, sensation, and prehension. During strength testing, selected upper extremity muscles are assessed for the grade of muscle contraction or power of the muscle. During sensation testing, specific zones on the palmar and dorsal aspects of the hand are tested with Semmes Weinstein Monofilaments (SWM) with varying weights. Prehension is assessed both qualitatively and quantitatively. During the qualitative section, no specific position is required, except that the hand should be positioned appropriately for movement with assistance from the examiner, if necessary. During quantitative section, participant is asked to perform six tasks and performance is graded.
Measured: From enrollment to the end of treatment at 4 weeks
NRS
Neuromuscular Recovery Scale Assessment (NRS) assesses the level of muscle activation and amount of external assistance required to perform motor tasks involving hand, arm, and trunk. The research participant will be asked to perform motor tasks as independently as possible. Research staff will score each of these tasks based on the algorithm. NRS consists of six sub-items focusing on UE function, including overhead press, shoulder flexion, grasp, door pull, open with key, and can open and manipulation. Items are scored from phase 1 to phase 4, the higher the phase, the better is the functional performance
Measured: From enrollment to the end of treatment at 4 weeks
Voluntary hand opening and closing kinematics
Three-dimensional kinematic data will be collected using a motion capture system. Reflective markers will be placed on the participant's forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening and closing task. Surface electrodes will be applied on the participant's skin to acquire EMG data.
Measured: From enrollment to the end of treatment at 4 weeks
Maximal voluntary grip strength
For maximal voluntary grip strength, participants will be instructed to apply as much force as possible while trying to grasp or making a fist around the grip handle during a 3 second audio cue. Each MVC attempt will be followed by a rest period of 20 seconds of no activity. A total of 5 grip strength attempts will be collected.
Measured: From enrollment to the end of treatment at 4 weeks
Transcranial magnetic stimulation motor evoked potential (MEP)
To obtain MEP, transcortical magnetic stimulation (TMS) will be delivered through a figure-of-eight coil using a monophasic current waveform to the optimal scalp position along the arm and hand representation of the primary motor cortex eliciting largest MEP (MEPmax) from targeted arm and hand muscles. Electromyographic (EMG) sensors will be applied on the participant's skin to acquire muscle data.
Measured: From enrollment to the end of treatment at 4 weeks
F-wave
120% of the maximum stimulation intensity causing plateauing of the M-wave will be used to elicit F-wave. Evoked responses will be recorded using low-noise, pre-amplified surface EMG electrodes placed on the arm and hand muscles to record signals.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (5)
Functional Neurophysiological assessment (FNPA)
The assessment will be performed with the participant in lying position. The participants will be asked to relax for a minimum of 5 minutes at the beginning of the assessment to acquire a baseline of the electrical noise in his/her muscles and in the room. Corresponding volitional motor tasks will then be performed to match the muscles being recorded at that time (elbow flexion to record from biceps brachii). Reflexive testing, including deep tendon reflexes, clonus, Babinski, and reaction to vibration may be performed after volitional testing.
Measured: From enrollment to the end of treatment at 4 weeks
Multisegmental Motor Response (MMR)
MMR will be evoked transcutaneously by using a constant current stimulator between the C2 spinous processes and the coccyx. The cathode(s) (pre-gelled, soft surface electrodes) will be placed over the skin between C2 spinous processes and the coccyx, while large anode(s) will be placed over the clavicle, abdomen, iliac bone or at different levels or at segments just below the cathode. The stimulus intensities will be adjusted for each testing condition, i.e. supine and sitting conditions. MMRs will be recorded bilaterally from hand and arm muscles and the trunk using low-noise, pre-amplified surface electromyographic electrodes placed on the skin over the muscle to record signal
Measured: From enrollment to the end of treatment at 4 weeks
Capabilities of Upper Extremity Questionnaire (CUE-Q)
The Capabilities of Upper Extremity Questionnaire (CUE-Q) is designed to assess functional capabilities of the upper extremities, specifically in individuals that have experienced a neurological injury. The CUE-Q is a 32-item questionnaire, scored by self-report through an interview with the participant. The 32 items assess six domains including unilateral (left and right) items, bilateral items, reaching items, pulling/pushing items, wrist items, and hand and finger items.
Measured: From enrollment to the end of treatment at 4 weeks
Spinal Cord Injury-Quality of Life (SCI-QOL) Questionnaire
The SCI-QOL was developed to address the shortage of psychometrically sound and relevant patient reported outcome measures available for clinical card and research in SCI rehabilitation. This questionnaire is accessible through computer adaptive testing and addresses the following domains: emotional health, physical-medical health, social participation, and physical function.
Measured: From enrollment to the end of treatment at 4 weeks
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) - ASIA Impairment Scale (AIS)
The ASIA Impairment Scale (AIS) is the most accepted classification in SCI that describes the level and severity of the injury, based upon the motor and sensory examination as described in the ISNCSCI for SCI. A "motor complete" injury (AIS A and B) is defined as an individual without motor sacral sparing (voluntary anal contraction) or sensory sacral sparing with motor function more than 3 levels below the motor level on either side. Motor incomplete injuries (AIS C and D) indicate some degree of sacral sparing and usually have voluntary movement in the lower extremities.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start2 Jan 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawan Sharma, PT. Ph.D., Kessler Foundation
- Investigators
- Gail Forrest, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698224
- Sponsor's protocol ID
- 1176828
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sharma P, Naglah A, Aslan S, Khalifa F, El-Baz A, Harkema S, D'Amico J. Preservation of functional descending input to paralyzed upper extremity muscles in motor complete cervical spinal cord injury. Clin Neurophysiol. 2023 Jun;150:56-68. doi: 10.1016/j.clinph.2023.03.003. Epub 2023 Mar 17.
PubMed 37004296Singh G, Sharma P, Forrest G, Harkema S, Behrman A, Gerasimenko Y. Spinal Cord Transcutaneous Stimulation in Cervical Spinal Cord Injury: A Review Examining Upper Extremity Neuromotor Control, Recovery Mechanisms, and Future Directions. J Neurotrauma. 2024 Sep;41(17-18):2056-2074. doi: 10.1089/neu.2023.0438. Epub 2024 Jul 12.
PubMed 38874496Sharma P, Panta T, Ugiliweneza B, Bert RJ, Gerasimenko Y, Forrest G, Harkema S. Multi-Site Spinal Cord Transcutaneous Stimulation Facilitates Upper Limb Sensory and Motor Recovery in Severe Cervical Spinal Cord Injury: A Case Study. J Clin Med. 2023 Jun 30;12(13):4416. doi: 10.3390/jcm12134416.
PubMed 37445450Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.
PubMed 33382659
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Spinal Cord and Peripheral Nerve Stimulation for Hand Function Recovery in Humans Post Cervical SCI
- ClinicalTrials.gov ID
- NCT06698224
- Acronym / sponsor ID
- 1176828
- Keywords
- Spinal cord injury, Hand function, Spinal cord stimulation, Paired stimulation, Physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Nov 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.
Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.
Detailed description
Cervical spinal cord injury (SCI) results in paralysis and/or weakness of arms and hands that severely affects the independence and quality of life post-injury. Therefore, regaining arm and hand function remains the top priority of this population. Considering that SCI is mostly incomplete in nature, recent evidence suggests that physical or occupational therapy training combined with spinal cord transcutaneous stimulation (scTS) is effective in restoring arm and hand function post-cervical SCI. scTS is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord to facilitate motor function post-SCI. The beneficial effects of scTS can be further improved by coupling it with peripheral nerve stimulation (PNS), which supplies the arm and hand muscles.
This study aims to investigate how precisely timed paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) combined with physical therapy can improve the use of arms and hands in those with a SCI. Spinal cord transcutaneous stimulation (scTS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the spinal cord to excite the nervous system for the activity being trained and promote connections between the brain and spinal cord. Peripheral nerve stimulation (PNS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the arm, forearm, and hand to excite the peripheral nerves and promote connections between the spinal cord and the muscles involved in the activity-based recovery training. We hypothesize that precisely timed application of scTS and PNS will increase spinal cord excitability. Increased spinal cord excitability coupled with physical therapy will facilitate hand function recovery post-SCI.
Study aims:
- To establish optimal time sequencing for the paired scTS and PNS delivery resulting in the spinal cord motor neuron excitability in non-injured (NI) and SCI participants.
- To investigate the acute effects of paired scTS and PNS delivery on spinal cord motor neuron and corticospinal excitability.
- To investigate the effectiveness of paired scTS and PNS along with scTS combined with AB-UET in recovering hand function post cervical SCI.
- To identify the potential mechanisms of action underlying the observed changes in the hand function following training with paired scTS and PNS along with scTS combined with AB-UET.
This is a pretest-posttest experimental design. SCI participants will be enrolled for Aims 1, 2, 3 and 4. For SCI participants, On site medical evaluation, ASIA Impairment Scale (ISNCSCI-AIS), MVC grip strength and nerve intactness study will be collected or performed during the screening process. If the individual is potentially eligible for the study, as determined by the study physician and investigators, they will undergo pre-training assessments, 20 training sessions, and post-training assessments. Non-Injured (NI) participants will be enrolled for Aims 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scTS | Active comparator | Device: Spinal cord transcutaneous stimulationThis arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy. |
| scTS+PNS | Experimental | Device: Paired spinal cord and peripheral nerve stimulationThis arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- Non-progressive cervical SCI
- Greater than or equal to 6-months post spinal cord injury
- Stable medical condition
- Viable median and ulnar nerve as evident from MMR and M-Wave recordings
Key exclusion criteria (23 listed)
- Ventilator Dependent
- Untreated fracture or pressure ulcer
- Untreated psychiatric disorder or ongoing drug abuse
- Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
- Skeletal muscle Botox injections less than 6 months prior
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 |
|---|---|---|
| Spinal cord transcutaneous stimulationPhysical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury. | Device | scTS |
| Paired spinal cord and peripheral nerve stimulationAlso: Spinal cord transcutaneous stimulation, Peripheral nerve stimulationPhysical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury. | Device | scTS+PNS |
Primary outcome
GRASSP
Time frame: From enrollment to the end of treatment at 4 weeks
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a 3-part assessment designed to measure participant's hand and arm function. The test specifically measures strength, sensation, and prehension. During strength testing, selected upper extremity muscles are assessed for the grade of muscle contraction or power of the muscle. During sensation testing, specific zones on the palmar and dorsal aspects of the hand are tested with Semmes Weinstein Monofilaments (SWM) with varying weights. Prehension is assessed both qualitatively and quantitatively. During the qualitative section, no specific position is required, except that the hand should be positioned appropriately for movement with assistance from the examiner, if necessary. During quantitative section, participant is asked to perform six tasks and performance is graded.
NRS
Time frame: From enrollment to the end of treatment at 4 weeks
Neuromuscular Recovery Scale Assessment (NRS) assesses the level of muscle activation and amount of external assistance required to perform motor tasks involving hand, arm, and trunk. The research participant will be asked to perform motor tasks as independently as possible. Research staff will score each of these tasks based on the algorithm. NRS consists of six sub-items focusing on UE function, including overhead press, shoulder flexion, grasp, door pull, open with key, and can open and manipulation. Items are scored from phase 1 to phase 4, the higher the phase, the better is the functional performance
Voluntary hand opening and closing kinematics
Time frame: From enrollment to the end of treatment at 4 weeks
Three-dimensional kinematic data will be collected using a motion capture system. Reflective markers will be placed on the participant's forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening and closing task. Surface electrodes will be applied on the participant's skin to acquire EMG data.
Maximal voluntary grip strength
Time frame: From enrollment to the end of treatment at 4 weeks
For maximal voluntary grip strength, participants will be instructed to apply as much force as possible while trying to grasp or making a fist around the grip handle during a 3 second audio cue. Each MVC attempt will be followed by a rest period of 20 seconds of no activity. A total of 5 grip strength attempts will be collected.
Transcranial magnetic stimulation motor evoked potential (MEP)
Time frame: From enrollment to the end of treatment at 4 weeks
To obtain MEP, transcortical magnetic stimulation (TMS) will be delivered through a figure-of-eight coil using a monophasic current waveform to the optimal scalp position along the arm and hand representation of the primary motor cortex eliciting largest MEP (MEPmax) from targeted arm and hand muscles. Electromyographic (EMG) sensors will be applied on the participant's skin to acquire muscle data.
F-wave
Time frame: From enrollment to the end of treatment at 4 weeks
120% of the maximum stimulation intensity causing plateauing of the M-wave will be used to elicit F-wave. Evoked responses will be recorded using low-noise, pre-amplified surface EMG electrodes placed on the arm and hand muscles to record signals.
5 secondary outcomes
Functional Neurophysiological assessment (FNPA)
Time frame: From enrollment to the end of treatment at 4 weeks
Multisegmental Motor Response (MMR)
Time frame: From enrollment to the end of treatment at 4 weeks
Capabilities of Upper Extremity Questionnaire (CUE-Q)
Time frame: From enrollment to the end of treatment at 4 weeks
Spinal Cord Injury-Quality of Life (SCI-QOL) Questionnaire
Time frame: From enrollment to the end of treatment at 4 weeks
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) - ASIA Impairment Scale (AIS)
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 37004296Sharma P, Naglah A, Aslan S, Khalifa F, El-Baz A, Harkema S, D'Amico J. Preservation of functional descending input to paralyzed upper extremity muscles in motor complete cervical spinal cord injury. Clin Neurophysiol. 2023 Jun;150:56-68. doi: 10.1016/j.clinph.2023.03.003. Epub 2023 Mar 17.
- Background: PubMed 38874496Singh G, Sharma P, Forrest G, Harkema S, Behrman A, Gerasimenko Y. Spinal Cord Transcutaneous Stimulation in Cervical Spinal Cord Injury: A Review Examining Upper Extremity Neuromotor Control, Recovery Mechanisms, and Future Directions. J Neurotrauma. 2024 Sep;41(17-18):2056-2074. doi: 10.1089/neu.2023.0438. Epub 2024 Jul 12.
- Background: PubMed 37445450Sharma P, Panta T, Ugiliweneza B, Bert RJ, Gerasimenko Y, Forrest G, Harkema S. Multi-Site Spinal Cord Transcutaneous Stimulation Facilitates Upper Limb Sensory and Motor Recovery in Severe Cervical Spinal Cord Injury: A Case Study. J Clin Med. 2023 Jun 30;12(13):4416. doi: 10.3390/jcm12134416.
- Background: PubMed 33382659Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.
- Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler FoundationLink provided by the sponsor.
- 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.
Gail Forrest, Ph.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord transcutaneous stimulation and Paired spinal cord and peripheral nerve stimulation in people with Spinal Cord Injury and Spinal Cord Disease, run by Kessler Foundation 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 23 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 20 Nov 2024. 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?
Contact LeighAnn Martinez (973-324-3557, lmartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRASSP (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698224, which also lists 4 linked publications.
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 20 Nov 2024.