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Deep Brain StimulationHoT-DBSNCT04965727

Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury

A study testing Device implantation in people with Deep Brain Stimulation and Neuro: Spinal Cord Injury, run by Jocelyne Bloch at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Device implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSwitzerland
Study dates
14 Jun 2021to Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Jocelyne Bloch, MD contact

41795562951

jocelyne.bloch@chuv.ch

Léa Bole-Feysot, MSc contact

lea.bole-feysot@chuv.ch

Switzerland1 site, 1 recruiting

  • CHUV

    Lausanne, Canton of Vaud, 1011

    Jocelyne Bloch, MD, 0041795562951, jocelyne.bloch@chuv.ch

    Léa Bole-Feysot, MSc, lea.bole-feysot@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Device implantation
Keywords
SCI, DBS, Spinal Cord Injury
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device implantationProcedure or surgery

    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).

Study groups in NCT04965727
Study groupRoleWhat they receive
Deep brain stimulationExperimentalParticipants 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.
Receives: Procedure: Device implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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)

    Measured: Through study completion, an average of 6 months

Secondary outcomes (3)

  1. 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

    Measured: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation

  2. Walking Index for Spinal Cord Injury (WISCI II)

    The WISCI II is an ordinal scale to assess walking function

    Measured: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation

  3. 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

    Measured: Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start14 Jun 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single site, interventional, non-randomized
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965727
Sponsor's protocol ID
HoT-DBS2021
Acronym
HoT-DBS
Status last verified
Sep 2023
First submitted
31 May 2021
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.

    PubMed 30247091

  • Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24.

    PubMed 30250140

  • Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.

    PubMed 30382197

  • Hou JM, Sun TS, Xiang ZM, Zhang JZ, Zhang ZC, Zhao M, Zhong JF, Liu J, Zhang H, Liu HL, Yan RB, Li HT. Alterations of resting-state regional and network-level neural function after acute spinal cord injury. Neuroscience. 2014 Sep 26;277:446-54. doi: 10.1016/j.neuroscience.2014.07.045. Epub 2014 Jul 30.

    PubMed 25086312

  • Cortes M, Medeiros AH, Gandhi A, Lee P, Krebs HI, Thickbroom G, Edwards D. Improved grasp function with transcranial direct current stimulation in chronic spinal cord injury. NeuroRehabilitation. 2017;41(1):51-59. doi: 10.3233/NRE-171456.

    PubMed 28505987

  • Kumru H, Benito-Penalva J, Valls-Sole J, Murillo N, Tormos JM, Flores C, Vidal J. Placebo-controlled study of rTMS combined with Lokomat(R) gait training for treatment in subjects with motor incomplete spinal cord injury. Exp Brain Res. 2016 Dec;234(12):3447-3455. doi: 10.1007/s00221-016-4739-9. Epub 2016 Jul 28.

    PubMed 27469242

  • Kim LH, Sharma S, Sharples SA, Mayr KA, Kwok CHT, Whelan PJ. Integration of Descending Command Systems for the Generation of Context-Specific Locomotor Behaviors. Front Neurosci. 2017 Oct 18;11:581. doi: 10.3389/fnins.2017.00581. eCollection 2017.

    PubMed 29093660

  • van den Brand R, Heutschi J, Barraud Q, DiGiovanna J, Bartholdi K, Huerlimann M, Friedli L, Vollenweider I, Moraud EM, Duis S, Dominici N, Micera S, Musienko P, Courtine G. Restoring voluntary control of locomotion after paralyzing spinal cord injury. Science. 2012 Jun 1;336(6085):1182-5. doi: 10.1126/science.1217416.

    PubMed 22654062

  • Sinnamon HM. Locomotor stepping elicited by electrical stimulation of the hypothalamus persists after lesion of descending fibers of passage. Physiol Behav. 1990 Aug;48(2):261-6. doi: 10.1016/0031-9384(90)90310-z.

    PubMed 2255729

  • Sinnamon HM. Preoptic and hypothalamic neurons and the initiation of locomotion in the anesthetized rat. Prog Neurobiol. 1993 Sep;41(3):323-44. doi: 10.1016/0301-0082(93)90003-b.

    PubMed 8105509

Questions about this trial

What is this clinical trial studying?

A study testing Device implantation in people with Deep Brain Stimulation and Neuro: Spinal Cord Injury, run by Jocelyne Bloch at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jocelyne Bloch, MD (41795562951, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965727, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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