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STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury. (STIMO)

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ClinicalTrials.gov Identifier: NCT02936453
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Ecole Polytechnique Fédérale de Lausanne
Foundation Wings For Life
Information provided by (Responsible Party):
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: 7 months after implant ]
    The Walking Index for Spinal Cord Injury is an ordinal scale that has been frequently used in clinical trials as a tool to assess walking function.
  • Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT) [ Time Frame: 7 months after implant ]
    10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: comfortable and fast. It yields scores that are valid and reliable for SCI individuals.
  • Safety and Preliminary efficacy: Weight Bearing Capacity (WBC). [ Time Frame: 7 months after implant ]
    Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02936453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Improvement of walking capability: Spinal Cord Independence Measure (SCIM III). [ Time Frame: 7 months after implant ]
    Spinal Cord Independence Measure (SCIM III) is a test used as a reference tool for the assessment of overall functional ability after SCI.
  • Improvement of walking capability: 6-Min Walk Test (6MWT). [ Time Frame: 7 months after implant ]
    This assessment is a submaximal test that will be used as a global and easy indicator of the locomotor performance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 29, 2019)
  • ASIA Impairment Scale (AIS) [ Time Frame: 7 months after implant ]
    The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury.
  • Modified Ashworth Scale (MAS) [ Time Frame: 7 months after implant ]
    The Modified Ashworth Scale is a method for measuring muscle spasticity. It involves manual movement of a limb through its range of motion to passively stretch specific muscle groups.
  • Berg Balance Scale (BBS) [ Time Frame: 7 months after implant ]
    The Berg Balance Scale was developed to measure balance among frail populations with impairment in balance function by assessing the performance of functional tasks with a 14-item scale.
  • Quality of life (pain, spasticity, bladder/bowel regulation, sex life and sleep) [ Time Frame: 7 months after implant ]
    A dedicated set of questionnaires is selected to monitor the quality of life (QoL). The questionnaires are dedicated to the social participation to society as well as to the self-reported problems affecting the QoL of SCI individuals (pain, spasticity, bladder/bowel regulation, sex life and sleep).
  • Neurobiomechanical recordings [ Time Frame: 7 months after implant ]
    Neurobiomechanical behaviour during different locomotor tasks will be recorded with a combination of kinematics, kinetics and EMG data.
  • Electrophysiological recordings and voluntary control of muscle contraction [ Time Frame: 7 months after implant ]
    A dedicated set of tests is selected to assess a variety of physiological parameters.
  • Short Pain Assessment [ Time Frame: 7 months after implant ]
    The pain assessment reports on the subjective feeling of pain during the previous week. It assesses the nature and location of pain and its interference with activities of daily living (ADL).
Original Other Pre-specified Outcome Measures
 (submitted: October 14, 2016)
  • ASIA Impairment Scale (AIS) [ Time Frame: 7 months after implant ]
    The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury.
  • Modified Ashworth Scale (MAS) [ Time Frame: 7 months after implant ]
    The Modified Ashworth Scale is a method for measuring muscle spasticity. It involves manual movement of a limb through its range of motion to passively stretch specific muscle groups.
  • Berg Balance Scale (BBS) [ Time Frame: 7 months after implant ]
    The Berg Balance Scale was developed to measure balance among frail populations with impairment in balance function by assessing the performance of functional tasks with a 14-item scale.
  • SF-36-item Short Form Health Survey (SF-36) [ Time Frame: 7 months after implant ]
    The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
  • Neurobiomechanical recordings [ Time Frame: 7 months after implant ]
    Neurobiomechanical behavior during different (loco)motor tasks will be recorded with a combination of kinematics, kinetics and EMG data.
  • Urodynamic Measurements [ Time Frame: 7 months after implant ]
    Patients will be assessed by urodynamic measurement using a Triton machine.
 
Descriptive Information
Brief Title  ICMJE STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.
Official Title  ICMJE Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)
Brief Summary

STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).

Patients will participate during 8-12 months, during which there will be:

  • Pre-implant evaluations (6-8 weeks)
  • Device implantation and stimulation optimization (6-8 weeks)
  • Overground rehabilitation training with EES (5-6 months). In the period after implantation, participants need to be present for testing and training, 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with training outside the rehabilitation room by making use of the Home-use system.

At the end of the protocol, the study aims to make the patients walk better and faster. As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.

Detailed Description

STIMO is a First-in-Man (FIM) study with the objective to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI), as it was previously successfully demonstrated in animals.

The study consists of two phases:

A. Main study

The main study lasts about 8-12 months for each individual participant, from signing informed consent to the final test in the study This period can be divided into 3 distinct phases:

  • Pre-implant : about 6-8 weeks from informed consent to implant. During this phase, patient will participate during a total of 6 distinct days of evaluations, of which 5 days in Lausanne and 1 day at the assessment center in Zurich. The patient will also participate to 3 weeks of pre-implantation training in a Body Weight Support (BWS) system.
  • Implant and stimulation optimization: about 6-8 weeks, including the implantation of the epidural lead and the neurostimulator. In this phase, the optimal stimulation parameters will be determined for the flexing and stretching of both legs. During this period, participants need to be present at the CHUV University Hospital in Lausanne 4-5 days per week (lodging can be provided).
  • Rehabilitation training and final evaluation: 4 days per week of rehabilitation training during a period of 5 months, followed by a final evaluation lasting 4 days in Lausanne and 1 day in Zurich. In this phase, the patients receive intensive overground rehabilitation training using a body weight support device in combination with EES, with the aim of significantly improving their walking capabilities. During this period, participants need to be present at the CHUV University Hospital in Lausanne (lodging can be provided) 4 days per week.

Once the patient has shown the ability to stand or walk safely without robotic assistance, he/she is offered the possibility to complement his/her neuro-rehabilitative training using EES outside the robotic environment and rehabilitation room by making use of the Home-use system.

B. Optional study extension (3 years)

The patient has the possibility to continue his/her neuro-rehabilitative training with the home-use system for an additional period of 3 years after the end of clinical rehabilitation period. During this period, evaluation measures and technical check-ups are made at regular time points. The patient is contacted monthly to ensure a normal training conduct and a safety follow-up.

At the end of the protocol, the study aims to make the patients walk better and faster. Improvements are quantified through pre-defined measures assessed prior to implant and at the end of the main study as well as at regular time points during the optional study extension.

As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Procedure: Device implantation
  • Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space
  • Implantation of Activa RC neurostimulator
Study Arms  ICMJE Experimental: All patients

Patients will participate during 8-12 months, during which there will be :

  • Pre-implant evaluations (6-8 weeks)
  • Device implantation and stimulation optimization (6-8 weeks)
  • Overground rehabilitation training with EES (5-6 months) In the period after implantation participants need to be present at the CHUV University Hospital in Lausanne 4 days per week for testing and training (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with a training outside the rehabilitation room by making use of the Home-use system.

An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.

Intervention: Procedure: Device implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
8
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65 (women or men)
  • Incomplete SCI graded as AIS A,B,C & D
  • Level of lesion: T10 and above, based on AIS level determination by the PI, with preservation of conus function
  • The intact distance between the cone and the lesion must be at least 60mm
  • Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
  • Minimum 12 months post-injury
  • Completed in-patient rehabilitation program
  • Able to stand with walker or 2 crutches
  • Stable medical and physical condition as considered by Investigators
  • Adequate care-giver support and access to appropriate medical care in patient's home community
  • Agree to comply in good faith with all conditions of the study and to attend all required study training and visits
  • Must participate in two training sessions before enrolment
  • Must provide and sign Informed Consent prior to any study related procedures

Exclusion Criteria:

  • Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  • History of significant autonomic dysreflexia
  • Cognitive/brain damage
  • Epilepsy
  • Patient who has spinal canal stenosis
  • Patient who uses an intrathecal Baclofen pump.
  • Patient who has any active implanted cardiac device such as pacemaker or defibrillator.
  • Patient who has any indication that would require diathermy.
  • Patient who has any indication that would require MRI.
  • Patient that have an increased risk for defibrillation
  • Severe joint contractures disabling or restricting lower limb movements.
  • Haematological disorders with increased risk for surgical interventions (increased risk of haemorrhagic events).
  • Participation in another locomotor training study.
  • Congenital or acquired lower limb abnormalities (affection of joints and bone).
  • Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding or not willing to take contraception.
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Spinal cord lesion due to either a neurodegenerative disease or a tumour.
  • Patient has other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
  • Patient is unlikely to survive the protocol follow-up period of 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Molywan Vat +41 21 314 12 93 molywan.vat@chuv.ch
Contact: Jocelyne Bloch, MD +41 21 314 12 93 jocelyne.bloch@chuv.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936453
Other Study ID Numbers  ICMJE STIMO2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Jocelyne Bloch
Collaborators  ICMJE
  • Ecole Polytechnique Fédérale de Lausanne
  • Foundation Wings For Life
Investigators  ICMJE
Study Chair: Grégoire Courtine Ecole Polytechnique Fédérale de Lausanne
Study Chair: Armin Curt University Hospital Balgrist, Zuerich
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP