ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury

Browse trials for

• Spinal Cord Injuries 1,948

Keywords

• SCI
• Spinal Cord Injury
• Epidural Electrical Stimulation
• Spinal Cord Stimulation
• ARC-IM Therapy

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 12 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne is the lead sponsor of 20 studies on the registry; 10 are open to participants now.

Study arms

• Experimental
  Subacute SCI

  Participants having sustained the injury less than 6 weeks prior to baseline (subacute). Participants will be provided with the ARC-IM Therapy.

  Device: ARC-IM Therapy

• Experimental
  Chronic SCI

  Participants having sustained the injury more than 1 year prior to enrollment (chronic). Participants will be provided with the ARC-IM Therapy.

  Device: ARC-IM Therapy

Interventions

• DeviceARC-IM Therapy

  All participants will be treated with ARC-IM Therapy. The ARC-IM Lumbar System is intended to deliver electrical impulses to the lumbosacral region of the spinal cord to support ambulatory functions in people with SCI.

Primary outcomes

1. Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to ARC-IM Therapy, from implantation up to the end of the study.

   Assess the preliminary safety of ARC-IM Therapy in participants with subacute and chronic SCI.

   Time frame: Continuously throughout the study (up to 6 years)

Secondary outcomes

1. American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI)

   The ASIA ISNCSCI is a clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.

   Time frame: At Eligibility, and at 6 weeks, 16 weeks, 42 weeks post-surgery

2. 10-Meter Walk Test (10MWT)

   The 10MWT assesses walking speed in meters per second over a short duration. It measures the time taken by the subjects to walk 10 meters. The test will be performed twice, at self-selected and at maximum velocity. Participants can use their habitual assistive device. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, ad 42 weeks post-surgery

3. 6-Minute Walk Test (6MWT)

   The 6MWT assesses endurance by measuring the distance in meters a participant walks in 6 minutes. Participants can use their habitual assistive device and can take as many standing breaks as they need, but the timer will not be paused. This test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

4. Timed Up and Go (TUG)

   The TUG evaluates functional mobility. Participants begin seated, then stand up, walk 3 meters, turn around, walk back, and sit down. The time taken to complete the sequence is recorded. Assistive devices may be used if necessary. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

5. Walking Index for Spinal Cord Injury version II (WISCI II)

   The WISCI II assesses the extent and nature of assistance a person with SCI requires to walk, using an ordinal scale of 20 levels, ranging from the most severe impairment (level 0) to the least severe impairment (level 20). The level is determined based on the use of assistive devices, braces, and the physical assistance of one or more persons. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

6. Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

   The SCI-FAI assesses functional walking ability. It is an observational gait assessment that includes 3 key domains of walking function, where 0 is the minimum and worst outcome: gait parameters (maximum score of 20 points), assistive device (each limb scored individually - maximum score of 14 points), and temporal distance (maximum score of 5 points). The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

7. Gait Analysis

   Multifactorial gait analysis that relies on high-precision recordings of whole-body kinematics and kinetics of each gait cycle will be performed. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

8. Goal Attainment Scale (GAS)

   The GAS is used to evaluate the participant's progress toward one or more personalized goal(s), which are individually defined by the participant. Each goal is scored on a standardized scale ranging from -2 (outcome is much less than expected) to +2 (outcome is much more than expected), allowing to assess to which extent the goal is met. The form will be completed for both with and without stimulation condition.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

9. Berg Balance Scale (BBS)

   The BBS assesses static and dynamic balance through 14 tasks, such as standing, reaching, and turning. Each item is scored on a 5-point scale (0-4) with higher scores meaning better ability to perform the assessed activity. Item scores are then summed, with a maximum score of 56. The use of assistive devices is not allowed. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery

Other outcomes

1. ARC-IM stimulation usage log

   Independent use of the ARC-IM Lumbar System by study participants will be evaluated through analysis of the ARC-IM stimulation usage log.

   Time frame: At 6 weeks, 16 weeks, 42 weeks post-surgery, and at the end of the study

2. Integration of ARC-IM Therapy within the standard-of-care

   Integration of ARC-IM Therapy within the standard-of-care for subacute SCI will be evaluated by quantifying its use within standard clinical mobility rehabilitation procedures. This will be achieved by extracting and comparing data of the Stimulation Usage Log and Participant's Calendar Log.

   Time frame: At 6 weeks, 16 weeks, and 42 weeks post-surgery

3. EES Evoked Muscle Response

   Effect of ARC-IM Therapy on the modulation of the spinal cord will be evaluated through electrophysiological assessments that will quantify the muscle responses to EES and adaptation of these responses over time.

   Time frame: Every 2 days during the mapping phase, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

4. Function In Sitting Test for Spinal Cord Injury (FIST-SCI)

   Effect of ARC-IM Therapy on trunk stability will be evaluated using the FIST-SCI. The FIST-SCI assesses sitting balance. It evaluates sensory, motor, proactive, reactive, and steady state balance factors based on 14 items, each scored on an ordinal scale from 0 to 4, where 0 means complete assistance is needed to perform the task successfully, and 4 means can complete the task independently and successfully. The test will be conducted both with and without stimulation.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks after surgery

5. Modified Ashworth Scale (MAS)

   Effect of ARC-IM Therapy on muscle tone will be evaluated using the MAS. The MAS assesses spasticity in a participant's upper and lower limb, by rating the resistance of a muscle to passive movement at a single joint on a 6-point nominal scale, where 0 means no increase in tone, and 5 means affected parts are rigid in flexion or extension. The clinical examination will be performed both with and without stimulation on different days at similar times. Antispastic medication and time points of test/medication intake will be documented.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

6. Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)

   Effect of ARC-IM Therapy on muscle tone will be evaluated using the SCATS. The SCATS assesses 3 types of spastic motor behaviors in SCI patients - clonus, flexor spasms, and extensor spasms. The clinical examination will be performed both with and without stimulation. Antispastic medication and start time of the test will be documented for inter-test reliability.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

7. Spinal Cord Injury - Quality of Life Short form (SCI-QoL SF)

   Effect of ARC-IM Therapy on quality of life will be evaluated with the SCI-QoL SF. The SCI-QoL SF is a PROM for individuals with SCI. It is divided into 4 domains (emotional health, physical-medical health, social participation, physical functioning) with a selection of 22 subdomains. Each subdomain has several items. The participant rates each item with a number between 1 and 5 according to the extent to which the statement it contains applies to them. Each subdomain is scored separately. The higher the score, the higher the participant's perceived quality of life.

   Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

8. EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

   Effect of ARC-IM Therapy on quality of life for chronic SCI participants will be evaluated with the EQ-5D-5L questionnaire. The EQ-5D-5L is a PROM that describes the patient's health state for five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

   Time frame: At Baseline, at 6 weeks, 16 weeks, and 42 weeks post-surgery, and yearly until the end of study

9. Patient Global Impression of Change (PGI-C)

   Effect of ARC-IM Therapy on the subjective change of overall status will be evaluated with the PGI-C. The PGI-C is a single-item questionnaire to measure the change of clinical status, injury severity, or injury improvement, and evaluate the response of a condition to the given therapy. It is a 7-point scale where the participant rates his/her improvement or deterioration on a scale from "1 = very much improved" to "7 = very much worse".

   Time frame: At 6 weeks, 16 weeks, and 42 weeks post-surgery

10. Spinal Cord Independence Measure (SCIM) III

    Effect of ARC-IM Therapy on functional independence in daily living will be evaluated with the SCIM III score. The SCIM III is a disability score that addresses functional ability in daily living in people with SCI. Three specific areas are assessed: self-care (0-20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The form will be filled out as per stimulation use of the participant in his/her daily life activities for with or without stimulation condition. Total score ranges between 0 and 100 points, with higher scores reflecting greater independence.

    Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

11. System Usability Scale (SUS)

    The SUS is a standardized post-usability test questionnaire comprised of 10 Likert-scale questions used to evaluate the usability of the investigational system. To collect the SUS score, participants rate how strongly they agree or disagree with statements on a 1 (strongly disagree) to 5 (strongly agree) scale.

    Time frame: At 6 weeks, 16 weeks, and 42 weeks post-surgery

12. EMSCI Pain Assessment Form (EPAF)

    Effect of ARC-IM Therapy on pain will be evaluated with the EPAF. The EPAF is used for classification of existing pain problems in people with SCI. The clinical assessment form consists of 12 items and follows the international guidelines and recommendations for the clinical documentation and assessment of pain in SCI. One overall form will be completed summarizing with and without stimulation condition.

    Time frame: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

13. Dual-Energy X-Ray Absorptiometry (DEXA)

    Effect of ARC-IM Therapy on bone mineral density will be evaluated using DEXA. Participants will lie in a supine position during the scan, following standardized protocols.

    Time frame: At Baseline and at 42 weeks post-surgery

14. Quantitative Computed Tomography (QCT)-Scan

    Effect of ARC-IM Therapy on muscle mass will be evaluated using QCT-Scan. The QCT-Scan is used to assess muscle mass by providing high-resolution cross-sectional images of the thigh and the trunk. It allows for precise measurement of muscle volume and composition. Participants will undergo the scan in a supine position, and standardized protocols will be used to ensure consistency across time points.

    Time frame: At Eligibility and at 42 weeks post-surgery

15. Additional User Feedback

    The Additional User Feedback is a form designed to collect qualitative feedback from participants regarding their interaction with the ARCIM Lumbar System. It includes rating items to evaluate satisfaction (from "not satisfied at all" to "very satisfied") and open-ended questions addressing ease of use, satisfaction with system components such as battery life, charging time, connection stability, and overall comfort during use.

    Time frame: At 6 weeks, 16 weeks, and 42 weeks post-surgery

Publications

• Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013. PubMed 24305828 ↗
• Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9. PubMed 36352232 ↗
• Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31. PubMed 30382197 ↗
• Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7. PubMed 35132264 ↗