Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury
NCT ID: NCT06773286
Last Updated: 2025-01-14
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-08
2025-12-31
Brief Summary
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* Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation?
* How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.
Participants will:
* Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks.
* Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.
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Detailed Description
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(Aim 1) To determine whether scTS+ABT intervention is safe when applied to persons with acute to subacute cervical SCI during inpatient rehabilitation. The investigators will evaluate the intervention safety based on the adverse event reports focusing three categories: (1) scTS-related (pain/discomfort and skin integrity), (2) ABT-related (musculoskeletal injuries, heart rate, and oxygen saturation levels), and (3) SCI-related (spasticity and autonomic dysreflexia). The type, frequency, and severity of adverse events reported in scTS+ABT group will be compared to those from ABT alone group. (Aim 2) To examine whether a 10-day regimen of scTS+ABT is feasible to apply to individuals with acute to subacute SCI during an inpatient rehabilitation program. The interest and willingness of participants to enroll and complete this study will provide insight into the feasibility of scTS+ABT intervention. The investigators will assess the feasibility based on quantitative data including ease of recruitment (accrual rate) and study completion rate and compare the study completion rate in scTS+ABT and ABT alone group. (Aim 3) To evaluate the efficacy of scTS+ABT intervention in promoting UE functional recovery in acute to subacute SCI, as compared to the sham control and ABT only. Given the greatest opportunity for recovery and neuroplasticity in acute-subacute SCI stage and the promising results demonstrated in the previous chronic SCI studies, the investigators expect that applying scTS+ABT at early stages would lead to greater UE function improvements compared to scTSsham+ABT and ABT only. UE motor impairment, voluntary handgrip strength, and UE functional ability will be quantitatively assessed three time at baseline, once at the end of intervention, and once at 1-, 2-, 3-month follow up. Within-group and between-group comparison will be made to evaluate the efficacy of different interventions. (Aim 4, Exploratory) To quantify and characterize the neurophysiological changes after scTS+ABT, as compared to the sham control or ABT alone. Previous chronic studies have suggested that scTS can increase the excitability of spinal network and activate the motor neurons within spinal cord distal to the lesion, leading to restoration of voluntary motor control. Here, the investigators will examine whether a 10-day regimen of scTS+ABT applied in the acute to subacute stage can also lead to neurophysiological gains. Pre-post changes in the cortical and spinal excitability will be measured and compared to the sham control and ABT only group. As an exploratory aim, the investigators will evaluated on a subset sample of each group (n=4).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training
Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Active Stimulation
Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training
The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Sham
The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Activity-based Training Only
Participants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.
Training only
articipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.
Interventions
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Active Stimulation
Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Sham
The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
Training only
articipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.
Eligibility Criteria
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Inclusion Criteria
* must have had a spinal cord injury for less than or equal to 8 weeks.
* must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
* must have some degree of motor dysfunction in the hand (bilateral UE motor score \<25).
* must be medically stable enough to participate in activity-based recovery training.
* must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
* must have ability to understand and the willingness to sign an informed consent.
Exclusion Criteria
* have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
* have a pressure sore or skin issues.
* have severe spasticity.
* in medically unstable condition.
* have a history of illicit drug abuse.
* have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
* unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
* unable to meet the attendance requirements.
* currently enrolled in another interventional research study.
* unable to follow instructions and maintain alertness during assessments and training.
18 Years
75 Years
ALL
No
Sponsors
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Kessler Foundation
OTHER
Responsible Party
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Fan Zhang
Principal Investigator
Principal Investigators
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Gail Forrest, PhD
Role: STUDY_DIRECTOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Fan Zhang, PhD
Role: backup
References
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de Freitas RM, Sasaki A, Sayenko DG, Masugi Y, Nomura T, Nakazawa K, Milosevic M. Selectivity and excitability of upper-limb muscle activation during cervical transcutaneous spinal cord stimulation in humans. J Appl Physiol (1985). 2021 Aug 1;131(2):746-759. doi: 10.1152/japplphysiol.00132.2021. Epub 2021 Jun 17.
Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
Popovic MR, Kapadia N, Zivanovic V, Furlan JC, Craven BC, McGillivray C. Functional electrical stimulation therapy of voluntary grasping versus only conventional rehabilitation for patients with subacute incomplete tetraplegia: a randomized clinical trial. Neurorehabil Neural Repair. 2011 Jun;25(5):433-42. doi: 10.1177/1545968310392924. Epub 2011 Feb 8.
Kloosterman MG, Snoek GJ, Jannink MJ. Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. Spinal Cord. 2009 Mar;47(3):196-203. doi: 10.1038/sc.2008.113. Epub 2008 Sep 30.
Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.
Zhang 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.
Freyvert Y, Yong NA, Morikawa E, Zdunowski S, Sarino ME, Gerasimenko Y, Edgerton VR, Lu DC. Engaging cervical spinal circuitry with non-invasive spinal stimulation and buspirone to restore hand function in chronic motor complete patients. Sci Rep. 2018 Oct 19;8(1):15546. doi: 10.1038/s41598-018-33123-5.
Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
Related Links
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Other Identifiers
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CSCR23ERG001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
40652
Identifier Type: -
Identifier Source: org_study_id
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