Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.
NCT01725880 — Spinal Cord Injury
Status: Terminated
http://inclinicaltrials.com/spinal-cord-injury/NCT01725880/
Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
Controversy exists regarding the optimal management of acute traumatic cervical spinal cord injury (SCI), especially those without bone injury. Although surgical decompression is often performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery continues to be a subject of intense debate. In this randomized controlled trial, the investigators compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. The purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.
NCT01485458 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT01485458/
Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.
NCT05426681 — Acute Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/acute-spinal-cord-injury/NCT05426681/
Spinal Cord Injury Neuroprotection With Glyburide; Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
The purpose of this study is to determine the safety of using oral Glyburide in patients with acute traumatic cervical spinal cord injuries (SCI).
NCT02524379 — Acute Spinal Cord Injury
Status: Terminated
http://inclinicaltrials.com/acute-spinal-cord-injury/NCT02524379/
Mean Arterial Pressure in Spinal Cord Injury (MAPS): Determination of Non-inferiority of a Mean Arterial Pressure Goal of 65 mmHg Compared to a Mean Arterial Pressure Goal of 85 mmHg in Acute Human Traumatic Spinal Cord Injury.
Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days after SCI as a clinical option. Unfortunately, the medical evidence to support this recommendation exists only at the clinical case series level (Class III data). Furthermore, maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated with risks to the patient via adverse medical events. Given this equivocal evidence, the investigators group has questioned the merit of sustained induced hypertension following acute SCI and has previously conducted a randomized, prospective controlled feasibility study to further examine this issue. This prior pilot study randomized patients with acute SCI to a spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure was defined as the change in American Spinal Injury Association (ASIA) motor score from baseline. No difference in the primary outcome was noted at one-year post-SCI in this study. In light of this pilot data, the investigators hypothesize that maintenance of normotension (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥ 65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority. Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one grade improvement in ASIA impairment scale, quality of life assessment (as measured by Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline, 72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded. The information gleaned from this trial will provide valuable information for the acute treatment of traumatic SCI and will serve the objective of optimizing current clinical practice and thus maximizing medical and neurological outcome for individuals following acute traumatic SCI.
NCT02232165 — Acute Spinal Cord Injury
Status: Terminated
http://inclinicaltrials.com/acute-spinal-cord-injury/NCT02232165/
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
NCT00654680 — Erectile Dysfunction
Status: Completed
http://inclinicaltrials.com/erectile-dysfunction/NCT00654680/
Optimisation of Patient Management Through Expediting the Spinal Clearance Process in the Major Trauma Patient
The Alfred Hospital receives approximately 40% of the major trauma patients in Victoria, all of whom are at risk for spinal injuries. The potential for spinal injuries necessitates the undertaking of appropriate spinal investigations, and a delay in the completion of these investigations exposes the patient to the risk of a missed diagnosis of spinal instability and of complications of immobility; the potential spinal patient is required to wear a neck collar and be nursed lying flat whilst awaiting the completion and the appropriate documentation of spinal X-ray investigations. The purpose of this study is to identify the issues causing a delay in the process of the completion of the appropriate spinal investigations and the documentation of the results. The outcome of the proposed research will be the development of a clinical management protocol to expedite the process, with the aim of optimising patient care and reducing complications.
NCT00163826 — Traumatic Brain Injury
Status: Completed
http://inclinicaltrials.com/traumatic-brain-injury/NCT00163826/
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN THE TREATMENT OF SPASTICITY AFTER TRAUMATIC BRAIN INJURY, SPINAL CORD INJURY OR IN MULTIPLE SCLEROSIS PATIENTS: AN OBSERVATIONAL STUDY
Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex. The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity. Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015). In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016). However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS). Interestingly, spasticity is a major concern for the rehabilitation of these patients. The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
NCT04673240 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04673240/
Trans-spinal Electrical Stimulation to Restore Upper Extremity Functions in Individuals With Traumatic Brain Injury (TBI) or spinal Cord Injury (SCI).
The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.
NCT04183998 — Traumatic Brain Injury
Status: Completed
http://inclinicaltrials.com/traumatic-brain-injury/NCT04183998/