Recruiting

Spinal Cord Stimulation

Sponsor:

University Health Network, Toronto

Code:

NCT03852381

Conditions

Neuropathic Pain

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulation

Study Details

Brief summary:

Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal columns but it is often associated with attenuation of analgesic benefit and lack of acceptance of paresthesias. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and to identify criteria for selecting patients based on monitoring of pain and its related domains in patients undergoing SCS trials. Achieving these objectives will increase probability of analgesic benefit while minimizing adverse effects and knowledge gains from this study will be applicable to other therapies for chronic pain conditions.

Conditions

Neuropathic Pain

Chronic Pain

Study ID

NCT03852381

Start date

May 16, 2019

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score > 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
2. Severity of pain > 3/10 on NRS and ODI score for disability >40/100; and
3. Pain refractory to conventional medical management tried for at least 3 months.

Exclusion Criteria:

1. Age < 18 or age ≥ 80 years;
2. Previous trial or implantation of SCS system;
3. Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection;
4. Pregnancy;
5. Opioid dose > 200 mg OMED;
6. Psychiatric or psychological disorder likely to impact perception of pain;
7. Inability to comply with the study interventions or evaluate treatment outcomes;
8. Mechanical spine instability as per flexion/extension lumbar X-rays;
9. Ongoing litigation issues related to the pain; and
10. Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spinal Cord Stimulation

At baseline, the following data will be recorded: standard-of-care questionnaire scores, neuroimaging (fMRI, MEG), psychophysical testing (QST), accelerometer sleep and activity data.

The trial will proceed as follows:

Day 1-4: Paresthesia-based SCS (PB-SCS)

Day 5-8: No SCS (placebo)

Day 9-12: PF-SCS

Neuroimaging and psychophysical testing will be conducted at the end of the trial, and will be assessed 6-months post-implantation of the SCS device along with adverse effects. A decision to implant the SCS system will be made based on reduction of patient pain intensity by 50% in PB-SCS and/or PF-SCS modes, but not with placebo SCS.

Based on the response in the trial, the patient will either not be a candidate for an SCS implant, or they will receive one of the four modes upon implantation (PB-SCS, or one of the three PF-SCS: Burst, High Frequency, High Density).

Interventions

Spinal Cord Stimulation

Paresthesia-based SCS(PB-SCS), with stimulating frequencies between 30 to 80 Hz that confer a tingling sensation. Three different paresthesia-free SCS (PF-SCS) modes that use frequencies in the range of 400-10,000 Hz include Burst, High Frequency stimulation at 1.2 kHz and High Density stimulation at 400 Hz.

Primary outcome measure

  • Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG [ Time Frame: 12 days after the initiation of the SCS trials ) ]
  • Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG [ Time Frame: 6 months after the initiation of the SCS implants ]
  • To measure long-term outcomes of novel PF-SCS modes including intensity and quality of pain, physical and psychological functioning, and patients' global impression of change [ Time Frame: 6 months after the initiation of the SCS implants. ]
  • Changes in sensory threshold with the novel PF-SCS modes as detected by QST [ Time Frame: 6 months after the initiation of the SCS implants ]

Central Contacts and Locations

Central contacts

Anuj Bhatia, MD FRCPC

(416) 603-5800anuj.bhatia@uhn.ca

Jamal Kara

(416) 603-5800jamal.kara@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Anuj Bhatia, MD FRCPC

(416) 603 5800anuj.bhatia@uhn.ca

Danielle Alvares

(416) 603 5800danielle.alvares@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • Spinal Cord Stimulation
  • Burst Stimulation
  • High Frequency Stimulation
  • High Density Stimulation
  • fMRI
  • MEG
  • QST

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-01-15.