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Intradural Percutaneous Stimulation

Primary Purpose

Pain, Chronic

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intradural Spinal Cord Stimulation

Administration of Questionnaires

About this trial

This is an interventional basic science trial for Pain, Chronic focused on measuring Percutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. 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
2. 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

Exclusion Criteria:

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
Untreated or active psychiatric condition
Complex regional pain syndrome or other condition that could limit testing or aggravate an ongoing medical condition
Unresolved issues of secondary gain (i.e. litigation)
The investigator deems that the subject is not suitable for the study even if they meet all other inclusive/exclusion criteria

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Intradural Spinal Cord Stimulation; Administration of Questionnaires

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Difference in Stimulation Intensity to induce paresthesias

Record the threshold difference in stimulation intensity between epidural and intrathecal stimulation. This will take the data collected from the patient's clinical epidural trial (paresthesia threshold) and compared to the patient's intradural threshold testing.

Unexpected/Chronic effects of stimulation

Record unexpected or unanticipated effects of stimulation that may limit its utility or conceivably provide a new avenue for neuromodulation not achievable with epidural stimulation. Participants will be contacted via telephone interviewed to screen for any unexpected outcomes.

Full Information

NCT ID

NCT03380104

First Posted

October 24, 2017

Last Updated

May 6, 2021

Sponsor

Matthew Howard

1. Study Identification

Unique Protocol Identification Number

NCT03380104

Brief Title

Intradural Percutaneous Stimulation

Official Title

Intradural Percutaneous Stimulation - Inducing Physiological Responses.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to obtain FDA IDE approval. Currently working on additional preclinical testing.

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Matthew Howard

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

In this pilot study the investigators will test an ability of intradural electrical stimulation in humans to elicit physiological responses (paresthesia or tingling sensation) and decrease pain when placed in the region of the thoracic spinal cord in a controlled manner. This subject population is comprised of patients that had previously failed various conservative pain management treatment plans and are deemed candidates for treatment of pain by spinal cord stimulation. The investigators will use commercially available device to deliver an intradural electrical stimulation to the spinal cord. This device is FDA approved for intracranial electrophysiological monitoring and delivery of electrical stimulation of the subsurface level of the brain. As a part of the study, the subject will be offered to complete the following questionnaires to assess quality of life and global function. These questionnaires will be completed prior the procedure and at specified time periods following the research intervention. The experimental portion of the procedure will follow the standard epidural spinal cord stimulator testing. Under fluoroscopic guidance, using a paramedian approach and shallow entry angle, the device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal cerebrospinal fluid (CSF) space and advanced to the T8-10 disc space. The stimulation catheter will run through a standardized experimental algorithm further described in greater details. The initial stimulation will last approximately 30 minutes and involve testing for paresthesias (tingling) and measurement of the threshold signal strength for onset of this sensation at 60 hertz (Hz) and 10000 Hz frequences. During this portion the subject will be asked to describe the sensations and rate his or her pain on a 0 to 10 scale. Following this initial stimulation, the frequency will be changed to 10 kilohertz (KHz) to run over the period of 4 hours. The investigators will continue evaluating the effects of stimulation using visual analogue scores during this period of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Chronic

Keywords

Percutaneous Electrical Nerve Stimulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Intradural Spinal Cord Stimulation; Administration of Questionnaires

Intervention Type

Device

Intervention Name(s)

Intradural Spinal Cord Stimulation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Administration of Questionnaires

Intervention Description

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.

Primary Outcome Measure Information:

Title

Establishment of paresthesia threshold

Description

Time Frame

30 minutes

Title

Establishment of motor threshold

Description

Time Frame

30 minutes

Title

Acute Adverse Pain Responses using short-form McGill Pain Questionnaire

Description

Time Frame

5 hours

Title

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

Description

Time Frame

5 hours

Secondary Outcome Measure Information:

Title

Difference in Stimulation Intensity to induce paresthesias

Description

Time Frame

90 minutes

Title

Unexpected/Chronic effects of stimulation

Description

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Untreated or active psychiatric condition Complex regional pain syndrome or other condition that could limit testing or aggravate an ongoing medical condition Unresolved issues of secondary gain (i.e. litigation) The investigator deems that the subject is not suitable for the study even if they meet all other inclusive/exclusion criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew A Howard, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17350527

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

23151433

Citation

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.

Results Reference

background

PubMed Identifier

24800260

Citation

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.

Results Reference

background

PubMed Identifier

25536035

Citation

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. Erratum In: PLoS One. 2015;10(4):e0123485.

Results Reference

background

PubMed Identifier

15983148

Citation

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.

Results Reference

background

PubMed Identifier

21992159

Citation

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.

Results Reference

background

PubMed Identifier

26585728

Citation

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.

Results Reference

background

PubMed Identifier

24654267

Citation

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.

Results Reference

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PubMed Identifier

23975646

Citation

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.

Results Reference

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PubMed Identifier

10442964

Citation

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.

Results Reference

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PubMed Identifier

27042909

Citation

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.

Results Reference

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Intradural Percutaneous Stimulation

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