Clinical Evaluation of Direct Dorsal Column Stimulation

NCT02020460 | Terminated

• 1 other identifier: Pro00036722
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the feasibility of Direct Dorsal Column Stimulation using existing Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and use of pain medications.

Conditions

Failed Back Surgery Syndrome

Keywords

post-laminectomy pain syndrome,; refractory,; refractory chronic neuropathic pain,; failed back surgery syndrome.

Outcome Measures

Primary Outcomes (1)

• Feasibility as measured by interview and questionnaire

  The subject will be asked to complete various questionnaires about their pain characteristics, consisting of pain rating scales and subjective recordings and ratings of stimulation intensity, duration, timing and location of pain.

  3-5 days after Successful SCS trial lead placement defined as at least 50% reduction in pain or adequate paresthesia coverage in the painful areas.

Study Arms (2)

Subdural trial lead

ACTIVE COMPARATOR

SCS trial lead in the subdural space.

Device: Subdural trial lead

Epidural trial lead

ACTIVE COMPARATOR

SCS trial lead in the epidural space.

Device: Epidural trial lead

Interventions

Subdural trial lead DEVICE

Subdural trial lead

Epidural trial lead DEVICE

Epidural trial lead

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary pain type-neuropathic with concordant neurologic findings
• Subject age is 18 years or older;
• Subjects who meet one of the following four criteria:
• diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome or failed back surgery syndrome.
• previously had successful SCS, but gradually became refractory
• did not have adequate coverage during a prior SCS trial,
• been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration
• Disease duration of at least 6 months with no lasting success with standard therapy and medications.
• Mean pain intensity of at least 5 cm (or greater), measured on a visual analog scale from 0 (no pain) to 10 cm (severe pain) on a 10 cm line;
• Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate;
• Subject is willing to cooperate with the study requirements including compliance with the treatment regimen, the follow-up visit schedule and completion of the study diary;
• Female candidates of childbearing potential must have a negative serum pregnancy test.
• MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) rules out a pathology that might compromise SCS electrode placement or pathology, in addition to neural compression that might contribute to the subject's pain
• Provide informed consent to participate in the study; -

You may not qualify if:

• A subject will be excluded from participation in this study if they meet any one of the following criteria:
• Pain attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis;
• Subjects currently participating in another clinical trial;
• Subject has an existing intrathecal drug pump
• Active local or systemic infection
• Unresolved issues of secondary gain (e.g., litigation)
• Expected inability to adequately report treatment outcome
• A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthritis of the hip associated with groin pain as primary complaint)
• Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis.
• Subjects who have a condition that requires diathermy or repeat MRI's;
• New medication for pain control has been initiated within 8 weeks prior to the initial baseline;
• Female candidates of child bearing potential who are pregnant (confirmed by positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child;
• Subject has a blood clotting disturbance or requires chronic anticoagulant drug therapy

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nandan Lad, MD, PhD

  DUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 25, 2013
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 8, 2017

Record last verified: 2015-08

Locations

US (1)