Direct Comparison of Spinal Cord Stimulator Parameter Settings

NCT05283863 | Completed Results

• 1 other identifier: 10-13-29
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

(Primary)

1. 1.To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire.
2. 2.To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain.
3. 3.To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.

Conditions

Spinal Cord Stimulation; High-frequency Stimulation; High-density Stimulation

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scale

  Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.

  8 weeks

Secondary Outcomes (4)

• Change in Brief Pain Inventory (BPI)

  8 weeks

• Change in SF-36

  8 weeks

• Pain Vigilance and Awareness Questionnaire (PVAQ)

  8 weeks

• Number of Patients With Side Effects of Stimulation

  8 weeks

Study Arms (2)

High-Frequency Stimulation, Then Placebo Stimulation

EXPERIMENTAL

Participants first receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks. After a 2-week washout period, they then receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks.

Device: High-frequency stimulation; Device: Sham Stimulation

Placebo Stimulation, Then High-Frequency Stimulation

SHAM COMPARATOR

Participants first receive sham spinal cord stimulation (1200 Hz at 0 V amplitude) for 2 weeks. After a 2-week washout period, they then receive sub-threshold high-frequency spinal cord stimulation (1200 Hz frequency, 200 μsec pulse width, and an amplitude 90% of the threshold for detection of a sensory percept) for 2 weeks.

Device: High-frequency stimulation; Device: Sham Stimulation

Interventions

High-frequency stimulation DEVICE

Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.

High-Frequency Stimulation, Then Placebo Stimulation; Placebo Stimulation, Then High-Frequency Stimulation

Sham Stimulation DEVICE

Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.

High-Frequency Stimulation, Then Placebo Stimulation; Placebo Stimulation, Then High-Frequency Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
• History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator

You may not qualify if:

• Significant dementia or other condition preventing informed consent by the patient.
• Current drug or alcohol abuse or dependence.
• Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
• Inability or unwillingness to cooperate with clinical testing.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44122, United States

Location

Related Publications (1)

• Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.

  PMID: 26481726 RESULT

Results Point of Contact

• Title: Jennifer Sweet, MD
• Organization: Case Western Reserve University

Jennifer.Sweet@UHhospitals.org

216-844-3192

Study Officials

• Jennifer A Sweet, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects underwent two weeks of conventional stimulation, followed by randomization to receive either subthreshold high-density (HD) or sham stimulation; this was followed by a crossover during which the participants who had received subthreshold HD stimulation were treated with sham and vice versa.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: March 17, 2022
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Locations

US (1)