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Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury (HoT-DBS)

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ClinicalTrials.gov Identifier: NCT04965727
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Ecole Polytechnique Fédérale de Lausanne
Information provided by (Responsible Party):
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois

Brief Summary:
The purpose of this study is to evaluate safety of Deep Brain Stimulation (DBS) of the lateral hypothalamus (LH) and whether the use of DBS can increase motor performance in patients with chronic spinal cord injury (SCI). The hypothesis, based on preclinical findings, is that DBS of the lateral hypothalamus can acutely augment leg motor function after SCI, and that the use of lateral hypothalamus DBS can be an adjunct during rehabilitation to promote recovery and long-term neuroplasticity.

Condition or disease Intervention/treatment Phase
Deep Brain Stimulation Neuro: Spinal Cord Injury Procedure: Device implantation Not Applicable

Detailed Description:

The investigators hypothesize that deep brain stimulation (DBS) delivered in the lateral hypothalamus (LH) can augment leg motor function in humans with SCI. DBS is a well-established neurosurgical technique that is used routinely in humans. For example, DBS is commonly used to regulate the activity of basal ganglia circuits in order to treat movement disorders like Parkinson's disease or tremor. For the past decade, the hypothalamus has been safely targeted to treat diseases such as obesity and cluster headache.

In this study, The investigators propose to test the safety and preliminary efficacy of Lateral Hypothalamus DBS in 3 individuals with incomplete SCI, as a potential basis for larger clinical trials. The investigators anticipate that such clinical trials will evaluate the respective impact of, and potential synergy between, DBS of the lateral hypothalamus and epidural electrical stimulation of the lumbar spinal cord to augment recovery from SCI.

The study intervention consists of 7 phases preceded by pre-screening:

  • Screening and enrolment
  • Baseline - Pre-implantation
  • Surgery
  • Calibration
  • Pre-rehabilitation
  • Rehabilitation
  • Post-rehabilitation

Measures will be performed before surgical intervention, after surgery but before training (Pre-rehabilitation), at regular intervals during training and at the end of the training phase (post-rehabilitation).

The study will take place at the CHUV (Lausanne, Switzerland). A total of 3 participants will be enrolled in the study and implanted with the Medtronic Percept PC and 2 Medtronic SenSight DIrectional lead (left and right LH). All participants will undergo the same treatment and procedures. The active duration of the study will be approximately 7 to 8 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single site, interventional, non-randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep brain stimulation

Participants will undergo a surgery for Deep Brain Stimulation (DBS). The neurostimulation system will be used for neuro-rehabilitation of the motor function.

Participants will follow a 3-month neuro-rehabilitation using DBS at a frequency of 3 times per week with physiotherapist.

Procedure: Device implantation
The intervention involves the insertion of lead electrodes (Medtronic SenSight Directional Lead) in the right and left lateral hypothalamus through craniotomy and an implantable pulse generator (Medtronic Model B35200 Percept™ PC) in the upper part of the pectoralis major (under the clavicle).




Primary Outcome Measures :
  1. Occurence of all SAEs and AEs that are deemed related or possibly related to study procedure or to study investigational system, from implantation up to the end of the study [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety of the approach in terms of tolerability of deep brain stimulation of the lateral hypothalamus in patients with chronic spinal cord injury (> 1 year)


Secondary Outcome Measures :
  1. Lower Extremity Motor Strength (M0-M5 score according to the AIS scale) [ Time Frame: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation ]
    The American Spinal Injury Association (ASIA) Standard Neurological CLassification of Spinal Cord Injury is a standard method of assessing the neuological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury

  2. Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation ]
    The WISCI II is an ordinal scale to assess walking function

  3. Walking speed (10MWT/6MWT) [ Time Frame: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation ]
    10 meter walk test (10MWT) and 6 minutes walk test (6MWT) are common tests used to measure walking speed and lomotor performance



Information from the National Library of Medicine

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

Inclusion Criteria:

  • SCI graded as American Spinal Injury Association Impairment Scale (AIS) C or D (able to walk independently for a few meters with a walker)
  • Focal spinal cord disorder caused by trauma
  • Minimum 12 months post-injury
  • Stable medical, physical and psychological condition as considered by Investigators
  • Able to understand and interact with the study team in French or English
  • Adequate care-giver support and access to appropriate medical care in patient's home community
  • Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
  • Must provide and sign Informed Consent prior to any study related procedures

Exclusion Criteria:

  • Limitation of walking function based on accompanying (CNS) disorders (i.e., systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  • History of significant autonomic dysreflexia
  • Cognitive/brain damage
  • Epilepsy
  • Use of an intrathecal baclofen pump
  • Any active implanted cardiac device such as pacemaker or defibrillator
  • Any indication that would require diathermy
  • Increased risk for defibrillation
  • Severe joint contractures disabling or restricting lower limb movements
  • Hematological disorders with increased risk for surgical interventions
  • Congenital or acquired lower limb abnormalities (affection of joints and bone)
  • Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breastfeeding
  • Lack of safe contraception for women of childbearing capacity
  • Spinal cord lesion due to either a neurodegenerative disease or a tumor
  • Gastrointestinal ulcers in the last five years
  • Known or suspected eye disorders or diseases
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Any 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
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Participation in another locomotor training study
  • Refusal to be informed of any finding during the study

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): NCT04965727


Contacts
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Contact: Jocelyne Bloch, MD 41795562951 jocelyne.bloch@chuv.ch
Contact: Molywan Vat, MSc 41795568979 molywan.vat@chuv.ch

Locations
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Switzerland
CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Jocelyne Bloch, MD    0041795562951    jocelyne.bloch@chuv.ch   
Contact: Molywan Vat, MSc    0041795568979    molywan.vat@chuv.ch   
Sponsors and Collaborators
Jocelyne Bloch
Ecole Polytechnique Fédérale de Lausanne
Investigators
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Principal Investigator: Jocelyne Bloch, MD CHUV
Publications:

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Responsible Party: Jocelyne Bloch, Professor, Neurosurgeon, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04965727    
Other Study ID Numbers: HoT-DBS2021
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois:
SCI
DBS
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System