Intradural Percutaneous Stimulation

NCT03380104 | Withdrawn FDA Device

• 1 other identifier: 201708754
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation.

Conditions

Pain, Chronic

Keywords

Percutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (4)

• Establishment of paresthesia threshold

  Observe and record how various stimulation measures induce paresthesias and record this paresthesia threshold. This will be measured by having the patient state when they feel paresthesias as the stimulation amplitude is increased. This will be recorded as a raw number.

  30 minutes

• Establishment of motor threshold

  Observe and record how various stimulation measures induce motor activity and record this motor threshold. This will be measured by having the patient state when they feel motor movement as the stimulation amplitude is increased. This will be recorded as a raw number.

  30 minutes

• Acute Adverse Pain Responses using short-form McGill Pain Questionnaire

  Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the short-form McGill Pain Questionnaire prior to start of testing and one hour following testing has concluded. The McGill Pain Questionnaire has a range of scores from zero (min) to 45(max) with lower numbers being better.

  5 hours

• Acute Adverse Pain Responses using long form Brief pain inventory (BPI)

  Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the long form BPI prior to start of testing and one hour following testing has concluded. The brief pain index creates a severity and interference score that ranges from zero (min) and 10 (max) with lower numbers being better.

  5 hours

Secondary Outcomes (2)

• Difference in Stimulation Intensity to induce paresthesias

  90 minutes

• Unexpected/Chronic effects of stimulation

  1 month

Study Arms (1)

Single Arm

EXPERIMENTAL

Intradural Spinal Cord Stimulation; Administration of Questionnaires

Device: Intradural Spinal Cord Stimulation; Behavioral: Administration of Questionnaires

Interventions

Intradural Spinal Cord Stimulation DEVICE

The device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal CSF space and advanced to the T8-10 disc space. After positioning of the intrathecal lead, the stimulation catheter will be run through a standardized experimental algorithm consisting on various frequencies.

Single Arm

Administration of Questionnaires BEHAVIORAL

Subjects will be administered questionnaires to evaluate pain, quality of life, and global function prior the study, at 1 hour after the completion of the study, and at 4 day follow-up appointment.

Single Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with neuropathic pain and concordant neurological findings previously consented for an epidural spinal cord stimulator trial
• Patients greater than 18 years of agree
• Must have one of the following:
• Diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome, or failed back surgery syndrome and planning to undergo a spinal cord stimulation trial
• Been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotic administration
• Disease duration of at least 6 months with no lasting success with standard therapies or medications with exception of spinal cord stimulation
• Mean pain intensity of a least 5 (or greater) measured on a visual analogue scale from 0 (no pain) to 10 (severe pain)
• MRI or CT Myelogram of the lumbar and thoracic spine (within 12 months prior to screening)
• No compressive spinal pathology or intradural implants (eg., syrinx shunt tubes)
• Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate
• Female patients of childbearing potential must have a negative serum pregnancy test
• Patients agree to comply with the study protocol and have reviewed and given written informed consent

You may not qualify if:

• Patients who are unable or unwilling to provide feedback regarding the response
• Subject has an existing intrathecal drug pump
• Pain is attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis
• Subject is currently enrolled in another trial
• History of coagulation disorders or patients on chronic anticoagulant or antiplatelet therapy that is not able to be safely held for 14 days
• History of thoracic trauma or spinal surgery extending into the thoracic spine
• History of arachnoiditis or intradural spinal surgery that would limit catheter insertion to the target site
• Current clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of the study endpoints (i.e. chronic migraine, significant arthritis of the hip associated with primary groin pain complaint)
• Radiographic evidence of frank spinal instability (gross mobile spondylolisthesis or abnormal subluxation requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis
• Subject has a condition that requires diathermy or repeated MRIs
• New medication for pain initiated within 8 weeks prior to initial baseline research evaluation
• Life expectancy less than 3 months
• Systemic infection or local infection of the spine or skin in the anticipated region of catheter insertion.
• Immune deficiency or history of post surgical infection
• Female candidates of childbearing potential who are pregnant (confirmed with a positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child

Sponsors & Collaborators

• Matthew Howard: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (12)

• Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.

  PMID: 17350527 BACKGROUND

• Crews JC, Chan VWS. Perioperative management of patients and equipment selection for neural blockade. In: Cousins MJ, Horlocker TT, Bridenbaugh PO, Carr DB, Eds., Neural Blockade in Clinical Anesthesia and Pain Medicine (Wolters Kluwer, Philadelphia, 2009), Chap. 8, 160-180. ISBN-13: 978-0-7817-7388-1

  BACKGROUND

• Flouty O, Oya H, Kawasaki H, Wilson S, Reddy CG, Jeffery ND, Brennan TJ, Gibson-Corley KN, Utz M, Gillies GT, Howard MA 3rd. A new device concept for directly modulating spinal cord pathways: initial in vivo experimental results. Physiol Meas. 2012 Dec;33(12):2003-15. doi: 10.1088/0967-3334/33/12/2003. Epub 2012 Nov 15.

  PMID: 23151433 BACKGROUND

• Gibson-Corley KN, Flouty O, Oya H, Gillies GT, Howard MA. Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. Biomed Res Int. 2014;2014:989175. doi: 10.1155/2014/989175. Epub 2014 Apr 1.

  PMID: 24800260 BACKGROUND

• Howell B, Lad SP, Grill WM. Evaluation of intradural stimulation efficiency and selectivity in a computational model of spinal cord stimulation. PLoS One. 2014 Dec 23;9(12):e114938. doi: 10.1371/journal.pone.0114938. eCollection 2014.

  PMID: 25536035 BACKGROUND

• Lena P, Martin R. Subdural placement of an epidural catheter detected by nerve stimulation. Can J Anaesth. 2005 Jun-Jul;52(6):618-21. doi: 10.1007/BF03015772.

  PMID: 15983148 BACKGROUND

• Pope JE, Stanton-Hicks M. Accidental subdural spinal cord stimulator lead placement and stimulation. Neuromodulation. 2011 Jan;14(1):30-2; discussion 33. doi: 10.1111/j.1525-1403.2010.00299.x. Epub 2010 Oct 7.

  PMID: 21992159 BACKGROUND

• Reddy CG, Dalm BD, Flouty OE, Gillies GT, Howard MA 3rd, Brennan TJ. Comparison of Conventional and Kilohertz Frequency Epidural Stimulation in Patients Undergoing Trialing for Spinal Cord Stimulation: Clinical Considerations. World Neurosurg. 2016 Apr;88:586-591. doi: 10.1016/j.wneu.2015.10.088. Epub 2015 Nov 14.

  PMID: 26585728 BACKGROUND

• Sharpe AN, Jackson A. Upper-limb muscle responses to epidural, subdural and intraspinal stimulation of the cervical spinal cord. J Neural Eng. 2014 Feb;11(1):016005. doi: 10.1088/1741-2560/11/1/016005.

  PMID: 24654267 BACKGROUND

• Toma AK, Papadopoulos MC, Stapleton S, Kitchen ND, Watkins LD. Systematic review of the outcome of shunt surgery in idiopathic normal-pressure hydrocephalus. Acta Neurochir (Wien). 2013 Oct;155(10):1977-80. doi: 10.1007/s00701-013-1835-5. Epub 2013 Aug 23.

  PMID: 23975646 BACKGROUND

• Tsui BC, Gupta S, Finucane B. Detection of subarachnoid and intravascular epidural catheter placement. Can J Anaesth. 1999 Jul;46(7):675-8. doi: 10.1007/BF03013957.

  PMID: 10442964 BACKGROUND

• Williams MA, Malm J. Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):579-99. doi: 10.1212/CON.0000000000000305.

  PMID: 27042909 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew A Howard, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor and Chairman

Model Details: All subjects enrolled in this study will undergo Intradural Spinal Cord Stimulation.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 20, 2017
• Study Start: June 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)