Sub-threshold DRG Stimulation vs Sham in Established Responders

NANot yet recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Neuropathic PainComplex Regional Pain Syndromes (CRPS)CausalgiaChronic PainLow Back PainPelvic 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.

Trial Locations (1)

90185

Neurokirurgiska kliniken. Neuromodulationsenheten, Umeå

All Listed Sponsors
lead

Umeå University

OTHER

NCT07170722 - Sub-threshold DRG Stimulation vs Sham in Established Responders | Biotech Hunter | Biotech Hunter