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Thread: Results of the Alternating Field stimulation Clinical trial in complete spinal cord injury

  1. #1

    Results of the Alternating Field stimulation Clinical trial in complete spinal cord injury

    The phase 1 trial at Purdue University applying Alternating electrical fields to patients with complete spinal cord injury bears more discussion. The trial studied 10 patients 18-65 years of age (all ASIA A). The stimulator was placed within 18 days after injury. All the patients were evaluated every 2 weeks and the stimulator was removed at 15 weeks. The only significant complication was infection in one patient. They found a mean improvement of 25.5 points of light touch sensation, 20.4 points of pinprick sensation, and 6.3 points motor score. Note that the sensory scores were based on a 0-2 scale for each dermatome. So a 20-point improvement would represent the return of 10 full dermatomes. This is more than would be expected for most patients with ASIA A injuries. The motor improvement was limited, however, to 6 points, the motor score is 0-5 per muscle and thus a 6-point improvement could be slight improvement of 6 muscles or substantial recovery of 1-2 muscles. This extent of recovery is more than would be expected from methylprednisolone alone. But, most interesting the return of leg somatosensory evoked potentials half of the patients.

    1. Shapiro, S, Borgens, R, Pascuzzi, R, Roos, K, Groff, M, Purvines, S, Rodgers, RB, Hagy, S and Nelson, P (2005). Oscillating field stimulation for complete spinal cord injury in humans: a phase 1 trial. J Neurosurg Spine. 2: 3-10. Departments of Neurosurgery and Neurology, Indiana University Medical Center, Indianapolis, Indiana, USA. SShapiro@iupui.edu. OBJECT: An electrical field cathode (negative pole) has trophic and tropic effects on injured spinal cord axons in in vitro and in vivo models of sea lamprey, rodent, and canine spinal cord injury (SCI) and it improves functional outcome. A human oscillating field stimulator (OFS) was built, a Food and Drug Administration (FDA) exemption number was obtained, and institutional review board approval was given for a Phase 1 trial to study 10 humans with complete motor and sensory SCI. METHODS: Entry criteria were complete SCI between C-5 and T-10 in patients 18 to 65 years of age and no transection demonstrated on magnetic resonance imaging. All participants received the National Acute Spinal Cord Injury Study (NASCIS) III methylprednisilone protocol. Cord compression and/or vertebral instability was treated before study entry. After treatment complete SCI (according to the American Spinal Injury Association [ASIA] score) remained in all patients with no somatosensory evoked potentials (SSEPs) below the injury level after surgery or for 48 hours. All patients underwent implantation of the OFS within 18 days. Patients underwent evaluation every 2 weeks postimplantation; the OFS was explanted at 15 weeks. Independent neurological status was assessed based on the ASIA score, visual analog scale (VAS) pain score, and SSEPs at 6 weeks, 6 months, and 1 year. Statistical analyses were performed using the two-tailed Wilcoxon test and analysis of variance (ANOVA). There were no complications at insertion of the OFS; there was one case of wound infection after explantation (5% infection rate). One patient was lost to follow up after 6 months. In all 10 patients the mean VAS pain score was 8 at implantation, 2 at 6 months, and in the nine attending follow up for 1 year it remained 2. At 1 year, the mean improvement in light touch was 25.5 points (ANOVA p < 0.001, Wilcoxon test p = 0.02), the mean improvement in pinprick sensation was 20.4 points [ANOVA p < 0.001, Wilcoxon test p = 0.02), and the mean improvement in motor status was 6.3 points [ANOVA p < 0.01, Wilcoxon test p = 0.02). Of five cases involving cervical cord injuries, bilateral upper-extremity SSEPs were normal in one, unilateral upper-extremity SSEPs were recovered in four, bilateral upper-extremity SSEPs were recovered in one, and abnormal lower-extremity SSEPs resolved in one case. In one of the five cases involving thoracic injuries an abnormal lower-extremity SSEP resolved. CONCLUSIONS: The use of OFS treatment in patients with SCI is safe, reliable, and easy. Compared with the outcomes obtained in compliant NASCIS III plegic patients, the results of the present study indicate efficacy, and the FDA has given permission for enrollment of 10 additional patients.

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    These are the results of the OFS (without drug delivery) stimulator trial involving human ASIA A acutes.
    Last edited by antiquity; 04-26-2006 at 08:16 AM.

  3. #3
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    METHODS: Entry criteria were complete SCI between C-5 and T-10 in patients 18 to 65 years of age and no transection demonstrated on magnetic resonance imaging.

    Thanks Seneca. No hemisection cut here? This is similar to the other thread we discussed (Link), isn’t it? Edit; it is - "Shapiro, S".
    Last edited by Leif; 04-26-2006 at 08:57 AM.

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    Seneca does that mean future trial participants will recieve a combination of OFS, methylprednisilone and another drug?
    thanks

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    Ian, seems like the other drug will be the small molecule called inosine.

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    Quote Originally Posted by Leif
    Ian, seems like the other drug will be the small molecule called inosine.
    Thanks leif , I just saw that in the other link. I couldnt see how they administered it though. Is it injected?
    Last edited by IanTPoulter; 04-26-2006 at 09:08 AM.

  7. #7
    Hi Ian. I noticed that all of these participants were treated with MP prior to implantation. I don't know if the guinea pigs in the chronic hemisection model received MP before being implanted and receiving the Inosine. If they did, I'm sure the article would have mentioned it.

    The Andara(TM) OFS PLUS System includes a drug pump which delivers inosine to the area of injury.
    I don't know how it reaches/penetrates the wound, via a tube or drip? Hopefully, Wise will elaborate.
    Last edited by antiquity; 04-26-2006 at 10:16 AM.

  8. #8
    The dogs mentioned did receive MP and also were decompressed. I don't know about the rodents.
    The dogs were all naturally injured mostly dachshounds that had a disc rupture had no pain perception in-between their toes..and were paralyzed in the rear limbs. Also incontinent.
    Life isn't about getting thru the storm but learning to dance in the rain.

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