Spinal Cord Stimulation for Restoring Walking Function in People with Spinal Cord Injury

Switzerland (ICTRP)

ID di studio ICTRP
NCT07234903 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
ARC-IM Therapy to support and promote recovery of ambulatory functions in people with subacute and chronic spinal cord injury (BASEC)

Titolo accademico
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury (ICTRP)

Titolo pubblico
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury (ICTRP)

Malattie studiate
Spinal Cord InjurySCISCI - Spinal Cord InjurySubacute Spinal Cord InjuryChronic Spinal Cord InjurySpinal Cord Injury (SCI) (ICTRP)

Intervento studiato
Device: ARC-IM Therapy (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

1. Must be at least 18 years old and no older than 65 years old at the time of
enrollment.

2. Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).

3. Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region
extending 6 cm above the tip of the conus remaining anatomically intact as
determined by MRI.

4. Must have sustained their injury either less than 6 weeks prior to baseline (Group
"Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI").

5. Must be suffering from a SCI due to trauma.

6. Must have a stable medical, physical and psychological condition as considered by
the investigators and the delegated specialists.

7. Must have residual upper limb function to use the arms for weight bearing support
(as determined by functional demonstration).

8. Must be able to understand and interact with the study team in German, French or
English.

9. Must agree to comply in good faith with all conditions of the study and to attend
all scheduled appointments.

10. Must provide Informed Consent as documented by signature prior to any study-related
procedures.

11. Must have an acceptable or highly effective method of contraception for women of
childbearing capacity.

Exclusion Criteria:

1. Must not be pregnant nor breastfeeding.

2. Must not have brain damage.

3. Must not have a history of epilepsy

4. Must not have participated in another clinical study using drugs or medical devices
within the 30 days preceding and during the present study.

5. Must not have previously been injected with stem cells in the spinal cord.

6. Must not have any diseases and conditions that would increase the morbidity and
mortality of SCI surgery.

7. Must not require ventilator support.

8. Must not have any existing contraindication to mobility functions (e.g., unhealed
bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).

9. Must not suffer from SCI from other etiology than trauma (ischemic, tumoral,
autoimmune, etc.).

10. Must not have any anatomical limitations in the implantation area as judged by the
investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone
damage at area of implantation).

11. Must not require the use of an intrathecal baclofen pump.

12. Must not have any active implanted devices.

13. Must not have any other conditions that would make the subject unable to participate
in testing in the judgment of the investigators (e.g., renal failure, hepatic
dysfunction, cardiovascular disease, etc.).

14. Must not be the investigator him/herself, his/her family members, employees or other
dependent persons. (ICTRP)

non disponibile

Endpoint primari e secondari
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to ARC-IM Therapy, from implantation up to the end of the study. (ICTRP)

Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI);American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI);10-Meter Walk Test (10MWT);6-Minute Walk Test (6MWT);Timed Up and Go (TUG);Walking Index for Spinal Cord Injury version II (WISCI II);Gait Analysis;Goal Attainment Scale (GAS);Berg Balance Scale (BBS) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Jocelyne Bloch, Prof. Dr. MDBjrn Zrner, PD Dr. med. Dr. sc. nat.Jocelyne Bloch, Prof. Dr. MD, jocelyne.bloch@chuv.ch, +41 79 556 29 51, CHUVSPZ (ICTRP)

ID secondari
EIGER (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07234903 (ICTRP)