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Treatment of Post-Stroke Central Pain

NCT07593313 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-18

No results posted yet for this study

Summary

To evaluate the short-term analgesic efficacy of stSCS combined with pharmacotherapy compared with pharmacotherapy alone in patients with CPSP, measured by Numerical Rating Scale (NRS) score immediately after treatment.

Conditions

  • Central Post-Stroke Pain

Interventions

PROCEDURE

stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Patients received stSCS in addition to conventional pharmacotherapy. stSCS Procedure: Under digital subtraction angiography (DSA) guidance, a temporary electrode (typically an 8-contact electrode) was percutaneously placed into the corresponding spinal cord segment (cervical C2-C4 or thoracic T8-T10, depending on the pain distribution area). The electrode was connected to an external stimulator to deliver continuous stimulation for 7-14 days. Stimulation parameters were as follows: frequency 40-60 Hz (conventional mode) or BurstDR mode, pulse width 210-450 μs, and amplitude individually adjusted based on the patient's sensory threshold (targeting a comfortable paresthesia covering the painful area). After the test period, the electrode was removed without a second-stage implantation. Postoperatively, patients continued receiving baseline pharmacotherapy, which could be reduced as appropriate.

DRUG

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Patients received conventional pharmacotherapy alone without any form of SCS. The medication regimen followed the 2025 International Association for the Study of Pain (IASP) recommendations, with gabapentin (starting at 300 mg/d, gradually titrated to 900-1800 mg/d based on tolerability, administered in 2-3 divided doses) or pregabalin (starting at 75 mg/d, gradually titrated to 150-300 mg/d in 2-3 divided doses) as the foundation, and could be combined with duloxetine (60-120 mg/d) or amitriptyline (25-75 mg at bedtime). Drug doses were individually adjusted by the attending physician according to patient response and tolerability.

Sponsors & Collaborators

  • Nanchong Central Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • China

Study Locations

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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 NCT07593313 on ClinicalTrials.gov