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A novel neuromodulation technique in the treatment of chronic pain.


- candidate number9279
- NTR NumberNTR2825
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2011
- Secondary IDs01-SMI-2010 Spinal Modulation, Inc.
- Public TitleA novel neuromodulation technique in the treatment of chronic pain.
- Scientific TitleA Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pain.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedchronic neuropathic pain
- Inclusion criteria1. Male or female ≥ 18 years old;
2. Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months;
3. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain;
4. Minimum baseline pain rating of 60 mm on the VAS;
5. Stable pain medication dosage for at least 30 days;
6. Stable neurologic function in the past 30 days.
- Exclusion criteria1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control;
2. Escalating or changing pain condition within the past month as evidenced by investigator examination;
3. Subject is currently involved in medically related litigation;
4. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump;
5. Subject currently has an active infection;
6. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device;
7. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation;
8. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-sep-2012
- Target number of participants30
- InterventionsThis intervention involves the placement of epidural leads that provide stimulation. Stimulation intensity and the amount of of stimulation during the day is controlled by the subject to the desired levels during the duration of the clinical trial. The mechanism of action is unknown. Subjects will be followed up for 12 months following implantation neurostimulator system. Trial duration is expected to be approximately 15-18 months.
- Primary outcome1. Device Safety as determined by adverse event reporting. Adverse event profiles are expected to be similar to currently approved devices. These can include infection, lead migration, etc;
2. Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias.
- Secondary outcome1. Pain relief (VAS);
2. Quality of Life (EQ-5D).
- TimepointsMultiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. Jeffery Kramer
- CONTACT for SCIENTIFIC QUERIESPhD. Jeffery Kramer
- Sponsor/Initiator Spinal Modulation, Inc.
- Funding
(Source(s) of Monetary or Material Support)
Spinal Modulation, Inc.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD27-mrt-2011 - 26-apr-2012


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