Spinal Cord InjuriesABT-TCSCSNCT06472986
Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)
A study testing Activity-based therapy and transcutaneous spinal cord stimulation in people with Spinal Cord Injuries and Spinal Cord Injury Cervical, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury Cervical
- What is being tested?
- Activity-based therapy and transcutaneous spinal cord stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2022to 30 Jun 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
- Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete**, B, C, D) between C1-C8
- Adults more than 18 years old
- At least 6 months post-spinal cord injury
- A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
- A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
- Individuals who are medically stable
Who cannot join
- Individuals with any other upper extremity deficit
- Unable to provide informed consent
- Unable to participate in an intensive rehabilitation outpatient program
- Spasticity that limits the range of motion greater than 50% for the elbow or wrist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M4G 3V9
Gita Gholamrezaei, PhD, 416-597-3422 ext. 6209, gita.gholamrezaei@uhn.ca
Urvashy Gopaul, PhD
About this study
Official title: Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.
Read the detailed description
The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury Cervical
- Being tested
- Activity-based therapy and transcutaneous spinal cord stimulation
- Keywords
- stroke, cerebrovascular accident, CVA
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity-based therapy and transcutaneous spinal cord stimulationOther
Activity Based Therapy (ABT) is a method of neuro-rehabilitation that incorporates a high intensity, long duration and effortful engagement from the individual receiving therapy, to garner improvements in sensory and motor function. The ABT constitutes 4 types of exercises including: cardio-fitness, resistance, postural/weightbearing and functional exercises. TransCutaneous Spinal Cord Stimulation (TCSCS) stimulates spinal networks in the cervical region to neuro-modulate the descending motor commands/motor intentions from the brain, which control the muscles. In tCSCS, electrical stimulation is delivered at a frequency of 30-50Hz at 500-1000µs between C3-C7. 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| ABT-TCSCS | Experimental | The participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation. Receives: Other: Activity-based therapy and transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standards of Neurological Classification of SCI (ISNCSCI)
The ISNCSCI will be used to establish severity of injury, classify the sample and establish inclusion for study to be administered by clinicians. The ISNCSCI evaluates both motor and sensory impairment to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. The severity of injury is graded as ASIA A = Complete, B (Sensory Incomplete), C (Motor Incomplete), D (Motor Incomplete), E (Normal).
Measured: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
The GRASSP Version 1 evaluates sensorimotor and prehension function of upper extremity impairment and hand function through three domains: Strength, Sensation and Prehension. It will be administered by clinicians and takes about 30-45 minutes to complete.
Measured: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Spinal Cord Independence Measure (SCIM)
The SCIM is a measure of independence and defines how much gain in global function one makes.
Measured: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
TRI hand function test (TRI-HFT)
TRI-HFT will be used as a measure of functional and performance change before and after intervention.
Measured: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Tactile Discrimination Test (TDT)
The TDT will be used to measure of ability to discriminate differences in finely graded texture.
Measured: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Secondary outcomes (1)
Neurophysiological Assessment using surface electromyography (EMG)
Neurophysiological Assessment using surface EMG will be used to determine the responses to ABT and TCSCS in multiple upper limb muscles. sEMG responses to cervical spinal stimulation will be recorded simultaneously in multiple upper limb muscles unilaterally on the 1) deltoid anterior, 2) deltoid posterior, 3) biceps brachii, 4) triceps brachii, 5) flexor carpi radialis, 6) extensor carpi radialis, 7) abductor pollicis brevis, and 8) first dorsal interosseous muscles.
Measured: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start7 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Sukhvinder Kalsi-Ryan, University Health Network, Toronto
- Investigators
- Sukhvinder Kalsi-Ryan, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472986
- Sponsor's protocol ID
- 20-6276
- Acronym
- ABT-TCSCS
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share the data from this study with any researchers outside this study.
Publications
Kirshblum S, Botticello A, Lammertse DP, Marino RJ, Chiodo AE, Jha A. The impact of sacral sensory sparing in motor complete spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):376-83. doi: 10.1016/j.apmr.2010.07.242.
PubMed 21353822Marino RJ, Burns S, Graves DE, Leiby BE, Kirshblum S, Lammertse DP. Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database. Arch Phys Med Rehabil. 2011 Mar;92(3):369-75. doi: 10.1016/j.apmr.2010.09.027.
PubMed 21353821Kalsi-Ryan S, Curt A, Verrier MC, Fehlings MG. Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia. J Neurosurg Spine. 2012 Sep;17(1 Suppl):65-76. doi: 10.3171/2012.6.AOSPINE1258.
PubMed 22985372Kalsi-Ryan S, Riehm LE, Tetreault L, Martin AR, Teoderascu F, Massicotte E, Curt A, Verrier MC, Velstra IM, Fehlings MG. Characteristics of Upper Limb Impairment Related to Degenerative Cervical Myelopathy: Development of a Sensitive Hand Assessment (Graded Redefined Assessment of Strength, Sensibility, and Prehension Version Myelopathy). Neurosurgery. 2020 Mar 1;86(3):E292-E299. doi: 10.1093/neuros/nyz499.
PubMed 31792501Kapadia N, Zivanovic V, Verrier M, Popovic MR. Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):167-86. doi: 10.1310/sci1802-167.
PubMed 23459270Gopaul U, Bayley MT, Kalsi-Ryan S. Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury. Physiother Res Int. 2025 Apr;30(2):e70036. doi: 10.1002/pri.70036.
PubMed 39927575
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06472986
- Acronym / sponsor ID
- ABT-TCSCS / 20-6276
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury Cervical
- Keywords
- stroke, cerebrovascular accident, CVA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.
Detailed description
The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-TCSCS | Experimental | Other: Activity-based therapy and transcutaneous spinal cord stimulationThe participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete**, B, C, D) between C1-C8
- Adults more than 18 years old
- At least 6 months post-spinal cord injury
- A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
- A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
Key exclusion criteria (4 listed)
- Individuals with any other upper extremity deficit
- Unable to provide informed consent
- Unable to participate in an intensive rehabilitation outpatient program
- Spasticity that limits the range of motion greater than 50% for the elbow or wrist
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 |
|---|---|---|
| Activity-based therapy and transcutaneous spinal cord stimulationActivity Based Therapy (ABT) is a method of neuro-rehabilitation that incorporates a high intensity, long duration and effortful engagement from the individual receiving therapy, to garner improvements in sensory and motor function. The ABT constitutes 4 types of exercises including: cardio-fitness, resistance, postural/weightbearing and functional exercises. TransCutaneous Spinal Cord Stimulation (TCSCS) stimulates spinal networks in the cervical region to neuro-modulate the descending motor commands/motor intentions from the brain, which control the muscles. In tCSCS, electrical stimulation is delivered at a frequency of 30-50Hz at 500-1000µs between C3-C7. 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. | Other | ABT-TCSCS |
Primary outcome
International Standards of Neurological Classification of SCI (ISNCSCI)
Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The ISNCSCI will be used to establish severity of injury, classify the sample and establish inclusion for study to be administered by clinicians. The ISNCSCI evaluates both motor and sensory impairment to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. The severity of injury is graded as ASIA A = Complete, B (Sensory Incomplete), C (Motor Incomplete), D (Motor Incomplete), E (Normal).
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The GRASSP Version 1 evaluates sensorimotor and prehension function of upper extremity impairment and hand function through three domains: Strength, Sensation and Prehension. It will be administered by clinicians and takes about 30-45 minutes to complete.
Spinal Cord Independence Measure (SCIM)
Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The SCIM is a measure of independence and defines how much gain in global function one makes.
TRI hand function test (TRI-HFT)
Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
TRI-HFT will be used as a measure of functional and performance change before and after intervention.
Tactile Discrimination Test (TDT)
Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The TDT will be used to measure of ability to discriminate differences in finely graded texture.
1 secondary outcome
Neurophysiological Assessment using surface electromyography (EMG)
Time frame: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
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 9 Jul 2024.
- Results publication: PubMed 21353822Kirshblum S, Botticello A, Lammertse DP, Marino RJ, Chiodo AE, Jha A. The impact of sacral sensory sparing in motor complete spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):376-83. doi: 10.1016/j.apmr.2010.07.242.
- Results publication: PubMed 21353821Marino RJ, Burns S, Graves DE, Leiby BE, Kirshblum S, Lammertse DP. Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database. Arch Phys Med Rehabil. 2011 Mar;92(3):369-75. doi: 10.1016/j.apmr.2010.09.027.
- Results publication: PubMed 22985372Kalsi-Ryan S, Curt A, Verrier MC, Fehlings MG. Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia. J Neurosurg Spine. 2012 Sep;17(1 Suppl):65-76. doi: 10.3171/2012.6.AOSPINE1258.
- Results publication: PubMed 31792501Kalsi-Ryan S, Riehm LE, Tetreault L, Martin AR, Teoderascu F, Massicotte E, Curt A, Verrier MC, Velstra IM, Fehlings MG. Characteristics of Upper Limb Impairment Related to Degenerative Cervical Myelopathy: Development of a Sensitive Hand Assessment (Graded Redefined Assessment of Strength, Sensibility, and Prehension Version Myelopathy). Neurosurgery. 2020 Mar 1;86(3):E292-E299. doi: 10.1093/neuros/nyz499.
- Results publication: PubMed 23459270Kapadia N, Zivanovic V, Verrier M, Popovic MR. Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):167-86. doi: 10.1310/sci1802-167.
- Derived from this study: PubMed 39927575Gopaul U, Bayley MT, Kalsi-Ryan S. Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury. Physiother Res Int. 2025 Apr;30(2):e70036. doi: 10.1002/pri.70036.
- Individual participant dataSharing planned: No. We do not plan to share the data from this study with any researchers outside this study.
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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.
Sukhvinder Kalsi-Ryan principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity-based therapy and transcutaneous spinal cord stimulation in people with Spinal Cord Injuries and Spinal Cord Injury Cervical, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Jul 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 Canada. 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 Urvashy Gopaul, PhD (416-597-3422 ext. 7996, urvashy.gopaul@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Standards of Neurological Classification of SCI (ISNCSCI) (time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS). The study lists 5 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 NCT06472986, which also lists 6 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 9 Jul 2024.