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Sub-threshold DRG Stimulation vs Sham in Established Responders

NCT07170722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-05

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if sub-threshold dorsal root ganglion (DRG) stimulation provides pain relief beyond placebo in adults with chronic neuropathic pain who already have an implanted DRG stimulator. The main questions it aims to answer are:

* Does sub-threshold DRG stimulation reduce daily pain intensity compared with sham stimulation?
* How does sub-threshold stimulation affect sleep, mood, and daily activity?

Researchers will compare active sub-threshold DRG stimulation to sham (device switched off) to see if stimulation has a genuine effect on pain and wellbeing.

Participants will:

* Be randomly assigned to receive either active sub-threshold DRG stimulation or sham stimulation for 5 days, followed by the opposite condition for another 5 days.
* Complete short electronic diaries twice daily about their pain, sleep, mood, and activity.
* Attend study visits for safety checks and assessments.

Conditions

  • Neuropathic Pain
  • Complex Regional Pain Syndromes (CRPS)
  • Causalgia
  • Chronic Pain
  • Low Back Pain
  • Pelvic Pain

Interventions

DEVICE

Subtreshhold DRG-S

Continuous electrical stimulation delivered through an implanted DRG neurostimulator. Amplitude is set individually to 80% of each participant's perception threshold, ensuring no paresthesia is produced. Frequency and pulse width remain unchanged from the participant's established therapeutic settings. This sub-threshold programming distinguishes the intervention from suprathreshold (paresthesia-based) DRG stimulation used in earlier studies.

OTHER

Sham

The implanted DRG stimulator remains switched off for the entire 5-day period. Device interrogation logs are masked to maintain blinding. No electrical stimulation is delivered, allowing a placebo-controlled comparison with active sub-threshold stimulation.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Pedram Tabatabaei Tabatabaei, M.D, Ph.D · Univeristy hospital of northern sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170722 on ClinicalTrials.gov