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Trial record 1 of 1 for:    Lausanne Spinal Cord Injury
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STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury. (STIMO)

This study is currently recruiting participants.
Verified January 2017 by Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
Sponsor:
ClinicalTrials.gov Identifier:
NCT02936453
First Posted: October 18, 2016
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ecole Polytechnique Fédérale de Lausanne
Information provided by (Responsible Party):
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
  Purpose

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 9-11 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).

At the end of the protocol, the study aims to make the patients walk better and faster, however, as this is the first study of its kind, success is not guaranteed.


Condition Intervention
Spinal Cord Injury Procedure: Device implantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)

Resource links provided by NLM:


Further study details as provided by Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 8
Study Start Date: July 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients

Patients will participate during 9-11 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).
Procedure: Device implantation
  • Implantation of Specify 5-6-5 lead in epidural space
  • Implantation of Activa RC neurostimulator

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 demonstrated successfully in animals.

The study lasts about 9-11 months for each individual participant, from signing informed consent to the final test in the study. The period can be divided in 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.
  • 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 4-5 days per week at the CHUV University Hospital in Lausanne (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 improving the walking capabilities of the patient significantly.

During this period, participants need to be present 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided).

At the end of the protocol, the study aims to make the patients walk better and faster, as is quantified through the pre-defined measures which are assessed prior to implant and at the end of the study.

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 (women or men)
  • Incomplete SCI graded as AIS 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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936453


Contacts
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

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Canton de Vaud, Switzerland, 1011
Contact: Jocelyne Bloch, MD    +41 21 314 12 93    jocelyne.bloch@chuv.ch   
Sponsors and Collaborators
Jocelyne Bloch
Ecole Polytechnique Fédérale de Lausanne
Investigators
Study Chair: Grégoire Courtine Ecole Polytechnique Fédérale de Lausanne
Study Chair: Armin Curt University Hospital Balgrist, Zuerich
  More Information

Additional Information:
Publications:

Responsible Party: Jocelyne Bloch, Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02936453     History of Changes
Other Study ID Numbers: STIMO2016
First Submitted: October 12, 2016
First Posted: October 18, 2016
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois:
Spinal Cord Injury
Epidural Electrical Stimulation
Robot-assisted

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System