Study of PM Modulation Therapy in Trial Phase

NCT03110601 | Completed Results FDA Device

• 1 other identifier: SGEN-2017PM1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Trialing of PM modulation therapy in patients with chronic intractable low back pain

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Relative to Baseline and After a Trial Period

  Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.

  Baseline and 4 days plus or minus 1 days

Study Arms (3)

Control - Conventional SCS

ACTIVE COMPARATOR

Conventional SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.

Device: Control - Conventional SCS

Washout Period

NO INTERVENTION

1 day where no stimulation is provided

Test - Stimgenics SCS

EXPERIMENTAL

Stimgenics SCS parameters for 4 days plus/minus 1 day using an external SCS modulator.

Device: Test - Stimgenics SCS

Interventions

Control - Conventional SCS DEVICE

Conventional SCS Parameters

Control - Conventional SCS

Test - Stimgenics SCS DEVICE

Stimgenics SCS Parameters

Test - Stimgenics SCS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
• Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
• Must be older than 18 years old.
• Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
• Appropriate candidate for spinal cord stimulation trial.
• Subjects must be on a stable dose of pain medication regimen for at least 1 month.
• Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff.
• Must be able to comply with the requirement of study visits and follow-up and phone visits.
• Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

You may not qualify if:

• Systemic infection.
• Any active implanted device.
• Previous experience with SCS therapy either during a trial or fully implanted
• Evidence of serious neurological, psychological or psychiatric disorders.
• Mechanical spinal instability.
• Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
• Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
• Human immunodeficiency virus (HIV) infection or a clinically significant infection.
• Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation.
• A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
• Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
• Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
• Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
• Medical condition or pain in other body areas that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
• Concurrent participation in another clinical study.

Sponsors & Collaborators

• Stimgenics LLC: lead

Study Sites (1)

StimGenics

Bloomington, Illinois, 61701, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Patients were evaluated during the trial phase.

Results Point of Contact

• Title: VP of Clinical Affairs
• Organization: Stimgenics

clinicalSG@stimgenics.com

309-662-4321

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: May 5, 2017
• Primary Completion: October 12, 2017
• Study Completion: October 12, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Locations

US (1)