Combined treatment of patients with stroke-type neurosyphilis
| ISRCTN | ISRCTN82897356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82897356 |
| Sponsor | The Fifth People’s Hospital of Suzhou |
| Funder | The Fifth People's Hospital of Suzhou |
- Submission date
- 17/06/2026
- Registration date
- 02/07/2026
- Last edited
- 02/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Minzhi Wu
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
No. 10 Guangqian Road, Xiangcheng District
Suzhou
215131
China
| Phone | +86 (0)15150187616 |
|---|---|
| wuminzhi1202025021@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Efficacy of hyperbaric oxygen therapy combined with ultrasound–neuromuscular electrical stimulation and traditional Chinese medicine acupuncture in patients with stroke-type neurosyphilis |
| Study objectives | |
| Ethics approval(s) |
Approved 31/12/2021, Fifth People’s Hospital of Suzhou ethics board (No. 10 Guangqian Road, Xiangcheng District, Suzhou, 215131, China; +86 (0)512-87806050; 17431664@qq.com), ref: SZWY20230913 |
| Health condition(s) or problem(s) studied | Stroke-type neurosyphilis |
| Intervention | Patients were randomised 1:1 into the experimental group or the control group using a computer-generated random number table. Control arm (standard care): Participants receive standard neurosyphilis care, including: 1. Antibiotic therapy with intravenous aqueous crystalline penicillin G (18–24 million units/day) for 14 days, followed by intramuscular benzathine penicillin G (2.4 million units) weekly for 3 weeks (ceftriaxone 2 g/day intravenously for 14 days is substituted for penicillin-allergic patients) 2. Secondary prevention with aspirin (100 mg/day) or clopidogrel (75 mg/day if intolerant), plus atorvastatin (20 mg/day) 3. Routine rehabilitation consisting of 45 minutes of supervised physical therapy and occupational therapy daily, 5 days per week, plus 45 minutes of home-based therapy with remote monitoring. Experimental arm: Participants receive all standard care interventions described above, plus three additional modalities administered concurrently, 5 days per week for 28 days (with 2 days of rest per week): 1. Hyperbaric oxygen (HBO) therapy 2. Transcranial ultrasound–neuromuscular electrical stimulation (TUS-NMES), delivered for 30 minutes once daily, with three ultrasound transducers positioned bilaterally above the zygomatic arches and at the lesion site (60% duty cycle, 0.54 W output power), and neuromuscular electrical stimulation applied through self-adhesive electrodes on affected limbs (pulse width 100 μs, frequency 300 Hz) 3. Traditional Chinese medicine acupuncture, performed by licensed practitioners with ≥5 years' experience, using stainless steel needles (0.25 × 40 mm) inserted at Baihui (GV20, obliquely 15–20 mm), Yintang (EX-HN3, transversely 10–15 mm), and the 'Ningxin' region (1 cm lateral to the midline between GV20 and GV24, bilaterally, perpendicular 10–15 mm), with Deqi sensation elicited, needles retained for 30 minutes with manual manipulation every 10 minutes, once daily. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 190 |
| Total final enrolment | 209 |
| Key inclusion criteria | 1. Positive serum and cerebrospinal fluid (CSF) Treponema pallidum particle agglutination 2. CSF white blood cell count >5/μL or elevated protein (>0.45 g/L) 3. Imaging-confirmed cerebral infarction (computed tomography [CT] or magnetic resonance imaging [MRI]) 4. Clinical presentation consistent with acute stroke (hemiparesis, aphasia, etc). All participants had neurological deficits with a National Institutes of Health Stroke Scale (NIHSS) score ≥5. |
| Key exclusion criteria | 1. Comorbid major neurological disorders 2. Contraindications to HBO therapy, TUS-NMES or acupuncture 3. Pregnancy or breastfeeding 4. Inability to comply with rehabilitation |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
17/06/2026: Study's existence confirmed by the Fifth People’s Hospital of Suzhou ethics board.
