Intradural Percutaneous Stimulation

Matthew Howard

Status

Withdrawn

Conditions

Pain, Chronic

Treatments

Behavioral: Administration of Questionnaires

Device: Intradural Spinal Cord Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03380104

201708754

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 85 years old

Volunteers

No 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