Treatment of Post-Stroke Central Pain

NCT07593313 | Recruiting

• 1 other identifier: 2025030
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) score

  The primary outcome was pain intensity measured by the NRS(0-10) recorded at baseline, immediately after stimulation termination (study group)/at the corresponding time point after treatment (control group), and at 1, 3, and 6 months post-treatment. The proportions of patients with an NRS reduction of ≥30% and ≥50% from baseline were also recorded, with the latter defined as treatment response. NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain.

  Six months

Secondary Outcomes (3)

• Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

  6 months

• Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)

  6 months

• Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)

  6 months

Study Arms (2)

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

EXPERIMENTAL

Patients received conventional pharmacotherapy alone without any form of SCS.

Drug: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

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

EXPERIMENTAL

Patients received stSCS in addition to conventional pharmacotherapy.

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

Interventions

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

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.

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

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) DRUG

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.

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of central post-stroke pain (CPSP) according to the International Association for the Study of Pain (IASP) criteria
• Clear history of stroke confirmed by cranial CT or MRI
• Pain occurring after stroke and distributed in body parts corresponding to central nervous system injury
• Pain with neuropathic characteristics (e.g., burning sensation, electric shock sensation, needle prick sensation)
• Pain not explained by other causes
• Age ≥ 18 years
• Pain duration ≥ 3 months
• Baseline pain Numerical Rating Scale (NRS) score ≥ 4 points
• Complete clinical data with follow-up time ≥ 6 months

You may not qualify if:

• History of chronic pain before stroke
• Severe cognitive impairment that prevents cooperation with pain assessment (Mini-Mental State Examination, MMSE \< 15 points)
• Contraindications to spinal cord stimulation (SCS), such as coagulation disorders, active infections, or mental diseases that prevent cooperation
• Malignant tumors or other severe organic diseases with expected survival \< 1 year

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Interventions

Pregabalin; Amitriptyline; Gabapentin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Central Study Contacts

Zhenguo Gao

CONTACT

18404999336; gaozhenguo0822@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 18, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

CN (1)