Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04965727
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2021-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Sponsor:
Jocelyne Bloch
Organization:
Study Overview
Official Title:
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HoT-DBS
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: