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

Primary Purpose

Deep Brain Stimulation, Neuro: Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Device implantation
Sponsored by
Jocelyne Bloch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Brain Stimulation focused on measuring SCI, DBS, Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep brain stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Lower Extremity Motor Strength (M0-M5 score according to the AIS scale)
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
Walking Index for Spinal Cord Injury (WISCI II)
The WISCI II is an ordinal scale to assess walking function
Walking speed (10MWT/6MWT)
10 meter walk test (10MWT) and 6 minutes walk test (6MWT) are common tests used to measure walking speed and lomotor performance

Full Information

First Posted
May 31, 2021
Last Updated
September 1, 2023
Sponsor
Jocelyne Bloch
Collaborators
Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT04965727
Brief Title
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Acronym
HoT-DBS
Official Title
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jocelyne Bloch
Collaborators
Ecole Polytechnique Fédérale de Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 (Optional and conditional): safety follow-up period 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. If deemed safe and beneficial by the Principal Investigator, participants may keep using the investigational device independently for 3 more years by entering the safety follow-up period at the end of the main study phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Brain Stimulation, Neuro: Spinal Cord Injury
Keywords
SCI, DBS, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single site, interventional, non-randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Device implantation
Intervention Description
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 Measure Information:
Title
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
Description
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)
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Lower Extremity Motor Strength (M0-M5 score according to the AIS scale)
Description
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
Time Frame
Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation
Title
Walking Index for Spinal Cord Injury (WISCI II)
Description
The WISCI II is an ordinal scale to assess walking function
Time Frame
Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation
Title
Walking speed (10MWT/6MWT)
Description
10 meter walk test (10MWT) and 6 minutes walk test (6MWT) are common tests used to measure walking speed and lomotor performance
Time Frame
Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne Bloch, MD
Phone
41795562951
Email
jocelyne.bloch@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Léa Bole-Feysot, MSc
Email
lea.bole-feysot@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyne Bloch, MD
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyne Bloch, MD
Phone
0041795562951
Email
jocelyne.bloch@chuv.ch
First Name & Middle Initial & Last Name & Degree
Léa Bole-Feysot, MSc
Email
lea.bole-feysot@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30247091
Citation
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Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury

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