Journal of neurosurgery
-
Journal of neurosurgery · Feb 1993
Randomized Controlled Trial Multicenter Study Clinical TrialIntrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study.
A total of 93 patients with intractable spasticity due to either spinal cord injury (59 cases), multiple sclerosis (31 cases), or other spinal pathology (three cases) were entered into a randomized double-blind placebo-controlled screening protocol of intrathecal baclofen test injections. Of the 88 patients who responded to an intrathecal bolus of 50, 75, or 100 micrograms of baclofen, 75 underwent implantation of a programmable pump system for chronic therapy. Patients were followed for 5 to 41 months after surgery (mean 19 months). ⋯ Only one patient withdrew from the study because of a late surgical complication (pump pocket infection). Another patient received an intrathecal baclofen overdose because of a human error in programming the pump. The results of this study indicate that intrathecal baclofen infusion can be safe and effective for the long-term treatment of intractable spasticity in patients with spinal cord injury or multiple sclerosis.
-
Journal of neurosurgery · Oct 1992
Case Reports Multicenter Study Clinical TrialEndovascular treatment of posterior circulation aneurysms by electrothrombosis using electrically detachable coils.
In a multicenter study, 120 patients with intracranial aneurysms presenting a high surgical risk were treated using electrolytically detachable coils and electrothrombosis via an endovascular approach. The results of treatment in patients with posterior fossa aneurysms (42 patients with 43 aneurysms) are presented. The most frequent clinical presentation was subarachnoid hemorrhage (24 cases). ⋯ It is suggested that this technique is a viable alternative in the management of patients with posterior fossa aneurysms associated with high surgical risk. Longer angiographic and clinical follow-up study is necessary to determine the long-term efficacy of this recently developed endovascular occlusion technique. Close postoperative angiographic and clinical monitoring of patients with wide-necked subtotally occluded aneurysms is mandatory to check for potential aneurysmal recanalization, regrowth, and rupture.
-
Journal of neurosurgery · Apr 1992
Randomized Controlled Trial Multicenter Study Clinical TrialEffect of AT877 on cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Results of a prospective placebo-controlled double-blind trial.
With the cooperation of 60 neurosurgical centers in Japan, a prospective randomized placebo-controlled double-blind trial of a new calcium antagonist AT877 (hexahydro-1-(5-isoquinolinesulfonyl)-1H-1,4-diazepine hydrochloride, or fasudil hydrochloride) was undertaken to determine the drug's effect on delayed cerebral vasospasm in patients with a ruptured cerebral aneurysm. A total of 276 patients, who underwent surgery within 3 days after subarachnoid hemorrhage (SAH) of Hunt and Hess Grades I to IV, were entered into the study. Nine patients were excluded because of protocol violation. ⋯ Furthermore, AT877 reduced the number of patients with a poor clinical outcome associated with vasospasm (moderate disability or worse on the Glasgow Outcome Scale at 1 month after SAH) by 54% (from 26% to 12%, p = 0.0152). There were no serious adverse events reported in the AT877 group. This is the first report of a placebo-controlled double-blind trial that has demonstrated a significant reduction in angiographically revealed vasospasm by intravenous drug therapy.
-
Journal of neurosurgery · Nov 1990
Multicenter Study Clinical TrialInitial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank.
In this prospective multicenter study, the authors have examined data derived from the initial computerized tomography (CT) scans of 753 patients with severe head injury. When the CT findings were related to abnormal intracranial pressure and to death, the most important characteristics of the scans were: midline shift: compression or obliteration of the mesencephalic cisterns: and the presence of subarachnoid blood. Diffuse hemispheric swelling was also found to be associated with an early episode of either hypoxia or hypotension.
-
Journal of neurosurgery · Jun 1989
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialChemonucleolysis versus discectomy: a randomized multicenter trial.
A randomized clinical trial was carried out to compare the results of open discectomy with those of chemonucleolysis in 151 patients suffering from a disc herniation at L4-5 or L5-S1. All patients fulfilled strict entry criteria; 78 patients underwent open discectomy and 73 were subjected to chemonucleolysis. An increase in radicular pain immediately after treatment was encountered in 16 patients (22%) in the chemonucleolysis group, as compared to none in the discectomy group. ⋯ Comparison of the final results of the two modes of treatment 12 months after the last intervention (including second treatment) did not reveal any significant differences. The duration of the preoperative symptoms, the level of disc herniation, and the leakage of contrast medium out of the disc appeared to be of no relevance to the final outcome. The complication rates in both treatment groups were low.