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Clinical Evaluation of Direct Dorsal Column Stimulation (DDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020460
Recruitment Status : Terminated (low accrual)
First Posted : December 25, 2013
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 25, 2013
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
Feasibility as measured by interview and questionnaire [ Time Frame: 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. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Direct Dorsal Column Stimulation
Official Title  ICMJE A Clinical Evaluation of Direct Dorsal Column Stimulation for the Management of Chronic, Medically Refractory Neuropathic Pain
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.
Detailed Description

Please note: This phase I feasibility study did not meet the expected enrollment goal of 75. The study only enrolled 6 subjects and therefore no participant completed phase II of the trial described below.

The primary objective of this study is to test the hypothesis that direct dorsal column stimulation is safe in the treatment of medically refractory, chronic neuropathic pain. 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.

Design & procedures This study is designed as a prospective, controlled exploratory study for an acute duration SCS trial system implantation. We will quantify perception of pain and stimulation-evoked paresthesias in response to both epidural and subdural direct dorsal column SCS. Additionally, we will measure the effects of both SCS modalities on somatosensory evoked potentials (SSEPs), patient quality of life, and satisfaction with treatment.

The normal clinical course of SCS for chronic pain includes a trial period of 3-30 days during which test stimulation is delivered via temporarily implanted epidural electrodes with an external percutaneous stimulation device. These electrodes are removed at the end of the trial period and, following a successful trial, a permanent set of electrodes and stimulation device are implanted at a later date. Subjects for this study will be recruited from patients planning to undergo percutaneous trial or paddle lead SCS implantation under the care of Dr. Nandan Lad at Duke University Medical Center.

Those subjects who a) have post-laminectomy pain syndrome and are considered good candidates for SCS trials, b) previously had successful SCS but have become refractory c) did not have adequate coverage during a prior SCS trial, or d) have been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration will be considered for participation.

Subjects recruited to this study will provide written informed consent prior to undergoing any research procedures (see "Selection of Subjects" below). Following consent and prior to surgery, we will record subject demographics and pain history, including age, sex, pain etiology, and history of prior pain-related surgeries. Subjects will then complete baseline assessments of pain using the revised short-form McGill Pain Questionnaire (SF-MPQ-2) and long form Brief Pain Inventory (BPI). Baseline measures for quality of life and global function will be measured with the EQ-5D-5L descriptive system and revised Self Assessment of Treatment (SAT) questionnaire, respectively.

After baseline measures have been recorded, the research study will be conducted in two phases. Study Phase I will occur during SCS implant surgery. First, an epidural trial SCS lead will be placed in accordance with the normal standard of care for this procedure. Next, a test stimulator (Cadwell ES-5) will be connected to the test lead and intraoperative test stimulation will be delivered for up to 30 minutes to determine the effect of spinal level, amplitude, frequency, pulse width on direct dorsal column stimulation. Sensation thresholds and paresthesia strength and coverage area will be recorded in response to these changes in stimulation parameters. SSEPs will be recorded throughout the procedure (Cadwell Cascade Elite IONM System). These will be recorded using needle electrodes placed on the tibial nerve and the scalp. Next, an Ad-tech subdural trial lead will be inserted in the standard fashion, similar to a standard lumbar drain catheter, and will be connected to the test stimulator. Test stimulation and quantification of responses will be repeated for up to an additional 30 minutes. The test stimulator will be disconnected once test stimulation is complete, and the surgery will continue per the normal standard of care to secure the two trial leads in place for post-operative percutaneous trial SCS.

Successful SCS trial lead placement is typically defined as at least 50% reduction in pain or adequate paresthesia coverage in the painful areas and the same threshold will be used for determining efficacy in both phases of the study. Subjects that do not meet either efficacy criterion will not be eligible to participate in the second phase of the study. The subdural trial electrode will be removed from these subjects, and they will continue with the normal clinical epidural SCS trial procedure.

Subjects entering Phase II of the study will be instructed to continue their usage of analgesic medications and other pain treatments as necessary, and will record any such use in the provided diary. This diary will also be used to query the subject for adverse events and side effects on a daily basis.

The second phase of the study will occur during the postoperative multi-day percutaneous SCS trial period. A hand-held trial stimulator typically used to deliver test stimulation during this trial period will be used to deliver stimulation for both standard care and the research study. A representative from St. Jude Medical (SJM) will work with each patient throughout the trial to program their system to its optimal setting, per the normal standard of care, but will not be involved in the collection of research data.

During the first half of study Phase II, trial SCS will be delivered to the subdural lead only (i.e. the epidural lead will be off). Methodological limitations prevent randomization of the order in which trial leads are activated in Phase II, so study staff will not be blinded to the location of the active SCS lead. However, subjects will not be told which trial lead is in use until the study is complete. The SJM representative will initially program the subdural trial lead on the day of surgery with standard stimulation settings. Subjects will assess their current pain intensity using a numeric rating scale (NRS) taken from the short-form BPI, item #6. Subjects will then be discharged from the hospital after receiving pain questionnaires and diaries to fill out over the next three days. On each of following two days, subjects will complete pain and quality of life ratings using the short from BPI, EQ-5D-5L descriptive system, and two NRS pain assessments; paresthesia coverage map and paresthesia quality ratings will also be completed to quantify sensory responses to SCS. On the third day following surgery, subjects will not complete NRS pain assessments, but will instead complete the SF-MPQ-2 and SAT in addition to the other ratings. This will conclude the first half of study Phase II.

The normal clinical course of trial stimulation will continue under the supervision of Dr. Lad and the SJM representative for up to 11 days to evaluate the efficacy of the trial SCS lead. Subjects will return to the Duke Spine Clinic (1B) at the end of this period for evaluation, x-ray imaging to confirm trial lead locations, and removal of the subdural trial lead. The epidural trial lead will then be activated, marking the beginning of the second half of study Phase II. All study procedures from the first half of Phase II will be repeated, this time using the epidural trial lead. Subjects will then continue normal clinical evaluation of the epidural trial lead with their care team, followed by removal of the epidural trial lead in the Duke Spine Clinic. The study team will review study participation with the subject and collect all remaining diaries at this time.

Description of Procedures performed:

The surgery is performed by the Principal Investigator, Dr. Nandan Lad MD, PhD.

Tuohy needle is percutaneously placed in the epidural space, using standard loss of resistance technique and a subdural stimulation lead is then passed and advanced under fluoroscopic guidance. The needle is then removed, and the lead is tested for stimulation and degree of pain relief. Figure of eight suture using 2.0 Silk is used to anchor to the skin.

Tuohy needle is then percutaneously placed in the lumbar subdural space, similar to a standard lumbar drain catheter insertion. An Ad-Tech lead is then passed and advanced under fluoroscopic guidance. The lead is tested for stimulation and degree of pain relief. The lead is anchored in place for post-operative percutaneous SCS trial (≤14 days). Figure of eight suture using 2.0 Silk is used to close the skin.

Trial leads will be removed by gently pulling and discarding the lead using the standard technique. All subjects will lay flat for 30 minutes to minimize the risk of low pressure headache following lead removal, consistent with standard practice for lumbar spinal catheters.

Selection of Subjects

It is anticipated that a total of 75 individuals will be studied. Subjects will be recruited from the Spine Clinic at Duke and overseen by Dr. Lad, respectively. Subjects will participate on a volunteer basis with informed consent approved by the Institutional Review Board of Duke University Medical Center. Apart from medically refractory chronic neuropathic pain, these individuals will be in good health. . The age range will be 18 years or older.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Condition  ICMJE Failed Back Surgery Syndrome
Intervention  ICMJE
  • Device: Subdural trial lead
  • Device: Epidural trial lead
Study Arms  ICMJE
  • Active Comparator: Subdural trial lead
    SCS trial lead in the subdural space.
    Intervention: Device: Subdural trial lead
  • Active Comparator: Epidural trial lead
    SCS trial lead in the epidural space.
    Intervention: Device: Epidural trial lead
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2013)
75
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects enrolled in this study must meet the following inclusion criteria:

  1. Primary pain type-neuropathic with concordant neurologic findings
  2. Subject age is 18 years or older;
  3. Subjects who meet one of the following four criteria:

    1. diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome or failed back surgery syndrome.
    2. previously had successful SCS, but gradually became refractory
    3. did not have adequate coverage during a prior SCS trial,
    4. been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration
  4. Disease duration of at least 6 months with no lasting success with standard therapy and medications.
  5. 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;
  6. Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate;
  7. 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;
  8. Female candidates of childbearing potential must have a negative serum pregnancy test.
  9. 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
  10. Provide informed consent to participate in the study; -

Exclusion Criteria:

A subject will be excluded from participation in this study if they meet any one of the following criteria:

  1. Pain attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis;
  2. Subjects currently participating in another clinical trial;
  3. Subject has an existing intrathecal drug pump
  4. Active local or systemic infection
  5. Unresolved issues of secondary gain (e.g., litigation)
  6. Expected inability to adequately report treatment outcome
  7. 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)
  8. Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis.
  9. Subjects who have a condition that requires diathermy or repeat MRI's;
  10. New medication for pain control has been initiated within 8 weeks prior to the initial baseline;
  11. 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;
  12. Subject has a blood clotting disturbance or requires chronic anticoagulant drug therapy
  13. The Investigator deems that the subject is not suitable for the study even if they meet all other inclusion/exclusion criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020460
Other Study ID Numbers  ICMJE Pro00036722
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nandan Lad, MD, PhD DUMC
PRS Account Duke University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP