Central Post-Stroke PainNCT07593313
Treatment of Post-Stroke Central Pain
A study testing stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) and Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) in people with Central Post-Stroke Pain, run by Nanchong Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Post-Stroke Pain
- What is being tested?
- stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) and Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Pain duration ≥ 3 months
- Baseline pain Numerical Rating Scale (NRS) score ≥ 4 points
- Complete clinical data with follow-up time ≥ 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Zhenhong 高, 18404999336, gaozhenguo0822@163.com
About this study
Official title: Efficacy and Safety of Short-Term Spinal Cord Stimulation Combined With Pharmacotherapy for Central Post-Stroke Pain: A Single-Center, Randomized, Controlled Trial
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
- Being tested
- stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline), Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)Procedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) | Experimental | Patients received conventional pharmacotherapy alone without any form of SCS. Receives: 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. Receives: Procedure: stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (3)
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality
Measured: 6 months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health
Measured: 6 months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jan 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Post-Stroke PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593313
- Sponsor's protocol ID
- 2025030
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Short-Term Spinal Cord Stimulation Combined With Pharmacotherapy for Central Post-Stroke Pain: A Single-Center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07593313
- Acronym / sponsor ID
- 2025030
- Conditions
- Central Post-Stroke Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) | Experimental | Drug: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)Patients received conventional pharmacotherapy alone without any form of SCS. |
| stSCS plus Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) | Experimental | Procedure: stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)Patients received stSCS in addition to conventional pharmacotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | stSCS plus Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) |
| 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. | Drug | Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) |
Primary outcome
Numerical Rating Scale (NRS) score
Time frame: Six months
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.
3 secondary outcomes
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
Time frame: 6 months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) and Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline) in people with Central Post-Stroke Pain, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Gao (18404999336, gaozhenguo0822@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) score (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.