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Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait (DBS-SCI)

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ClinicalTrials.gov Identifier: NCT03053791
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Balgrist University Hospital
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face a life in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment options exist. One of the most plastic systems involved in locomotion is the pontomedullary reticulospinal tract, which is the oldest locomotor command system existing in most vertebrates, including primates. Muscle activation patterns for limb movements are programmed in the spinal cord and have to be activated and coordinated through commands from the so called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower mesencephalic tegmentum sending uni- and bilateral signals through the medullary reticulospinal tracts. Classical physiological studies showed that electrical stimulation of the MLR induce locomotion. For the first time this approach was transferred and recently published in a model of induced incomplete spinal cord injury by the Schwab group. Rats severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a clinical standard treatment option in patients with movement disorders but does not relieve all symptoms. Therefore, small studies of MLR stimulations have been safely used in Parkinsonian patients showing freezing of gait and frequent falls with variable results. In a translational approach, we aim at performing a multidisciplinary phase one clinical trial with 5 patients and incomplete spinal cord injury. With the means of our established universitary setup for DBS treatments the operations will be performed unilaterally under local anaesthesia in the Division of Neurosurgery, USZ, with perioperative electrophysiological recordings, clinical assessments and gait analysis under test stimulation in the Spinal Cord Injury Center Balgrist.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Deep brain stimulation in mesencephalic locomotor region Device: Implantation of a Deep brain stimulation system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group of patients with spinal cord injury and spared fibers.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open-label Single Center Trial to Evaluate Safety and Preliminary Efficacy of Unilateral Deep Brain Stimulation of the Mesencephalic Locomotor Region in Patients With Incomplete Spinal Cord Injury
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention group
Single-armed study. All patients will receive treatment.
Procedure: Deep brain stimulation in mesencephalic locomotor region
Implantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait
Device: Implantation of a Deep brain stimulation system
Implantation of a Medtrinic Activa SC Impulse Generator for chronic Stimulation of the selected target.



Primary Outcome Measures :
  1. Change in 6 Minute Walk Test at baseline and 6 months post intervention [ Time Frame: preoperative, 6 months post intervention ]
    Standardized test. Patient is asked to walk for 6 minutes. Result is the distance covered


Secondary Outcome Measures :
  1. Change in Timed Up and Go test (TUG) towards baseline [ Time Frame: preoperative, 4-9 days postop, 14 days postop, 1,3,6 months postop ]
    Standardized test. Patient is asked to stand up from a sitting into Standing Position and walk 3 m. Result ist time.

  2. Change in 6 Minute Walk Test towards baseline [ Time Frame: preoperative, 4-9 days postop, 14 days postop, 1,3 months postop ]
    Standardized test. Patient is asked to walk for 6 minutes. Result is the distance

  3. Change in Spinal cord Independence measure (SCIM III) towards baseline [ Time Frame: preoperative, 4-9 days postop, 14 days postop, 1,3,6 months postop ]
    Standardized tool measuring the degree of independence of the subject. Result is score.

  4. Change in Walking index for spinal cord injury (WISCI II) towards baseline [ Time Frame: preoperative, 4-9 days postop, 14 days postop, 1,3,6 months postop ]
    Standardized tool measuring the subject's ability to walk. Result is score.

  5. Change in Quality of life towards baseline [ Time Frame: preoperative, 1,3,6 months postop ]
    Standardized QOL tool (SF-36). Result is score.

  6. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Standardized tool QUALIVEEN. Result is score.

  7. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Drink Portion (result is mL)

  8. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Urine Portion (result is mL)

  9. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Urge (result is score 0-4)

  10. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Unwanted loss of Urine (result is semi-quantitative no/Little/some/a lot)

  11. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Change of diapers (yes/no)

  12. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. Quality of diapers (semi-quantitative dry/moist/wet)

  13. Change in bladder function towards baseline [ Time Frame: preoperative, 6 months postop ]
    Bladder diary. pain (semi-quantitative 0-10)

  14. Change in sexual functions towards baseline [ Time Frame: preoperative, 6 months postop ]
    Use of the standardized tools FSFI (Female Sexual Function Index), result is score respectively IIEF (International Index of Erectile Function), result is score

  15. Change in spasticity towards baseline [ Time Frame: preoperative, 4-9 days postop, 14 days postop, 1,3,6 months postop ]
    Use of the standardized tool MAS (Modified Ashword Scale). Result is score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed Consent as documented by signature
  2. Must participate in two assessment sessions before enrollment
  3. Willingness and ability to comply with the protocol
  4. Male or female subjects
  5. Age 18-75
  6. Motor incomplete SCI
  7. Level of lesion: T10 and above, based on AISA level, preservation of sacral function
  8. Focal spinal cord disorder caused by either trauma or non-traumatic and non-progressive condition
  9. Minimum 6 months after original incident
  10. Completed in-patient rehabilitation program
  11. WISCI II, level >2 (0-20 items): assistance of one or more persons. Ability to walk at least 10 meters
  12. SCIM-III Mobility sub score >2 on the Mobility Indoors, Mobility for Moderate Distances
  13. Stable medical and physical condition.
  14. Adequate care-giver support

Exclusion Criteria:

  1. Enrollment of the investigator, his/her family members, employees
  2. Limitation of standing and walking function based on accompanying (CNS) disorders
  3. Cardiovascular disorders
  4. Autonomic dysreflexia
  5. Cognitive/brain damage
  6. Drug refractory Epilepsy
  7. Severe joint contractures disabling or restricting lower limb movements
  8. Haematological disorders
  9. Participation in another study with investigational drug within the 30 days preceding and during the present study
  10. Congenital or acquired lower limb abnormalities
  11. Women who are pregnant or breast feeding or planning a pregnancy during the course of the study
  12. Lack of safe contraception
  13. Inability to follow the procedures of the study
  14. Known or suspected non-compliance, drug or alcohol abuse
  15. Current or prior malignancy

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): NCT03053791


Contacts
Contact: Lennart H Stieglitz, MD +4144255 ext 9905 Lennart.Stieglitz@usz.ch
Contact: Andrea Prusse +4144386 ext 1111 DBS-SCI@balgrist.ch

Locations
Switzerland
Balgrist University Hospital Recruiting
Zurich, Switzerland, 8008
Contact: Andrea Prusse    +4144386 ext 1111    DBS-SCI@balgrist.ch   
Principal Investigator: Armin Curt, MD         
Sponsors and Collaborators
University of Zurich
Balgrist University Hospital
Investigators
Principal Investigator: Lennart H Stieglitz, MD University Hospital Zurich, Neurosurgery

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03053791     History of Changes
Other Study ID Numbers: SNCTP000000598
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
Deep brain stimulation
DBS
Spinal cord injury
SCI
Paraplegia
Mesencephalic locomotor region
MLR
Pedunculopontine nucleus
PPN

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