Deep brain stimulation of the lateral hypothalamus to enhance motor function in patients with spinal cord injury

Switzerland (ICTRP)

ID di studio ICTRP
NCT04965727 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Deep brain stimulation of the lateral hypothalamus to augment motor functions of patients with spinal cord injury (BASEC)

Titolo accademico
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury (ICTRP)

Titolo pubblico
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury (ICTRP)

Malattie studiate
Deep Brain Stimulation;Neuro: Spinal Cord Injury (ICTRP)

Intervento studiato
Procedure: Device implantation (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years

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
(ICTRP)

non disponibile

Endpoint primari e secondari
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 (ICTRP)

Lower Extremity Motor Strength (M0-M5 score according to the AIS scale);Walking Index for Spinal Cord Injury (WISCI II);Walking speed (10MWT/6MWT) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Ecole Polytechnique F?d?rale de Lausanne (ICTRP)

Contatti aggiuntivi
Jocelyne Bloch, MD;Jocelyne Bloch, MD;Jocelyne Bloch, MD, jocelyne.bloch@chuv.ch, 41795562951;0041795562951, CHUV, (ICTRP)

ID secondari
HoT-DBS2021 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04965727 (ICTRP)