Neuromodulation techniques for treating central post-stroke pain
Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
This study is testing if new brain stimulation techniques can help people with central post-stroke pain feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05708729 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of neuromodulation techniques, specifically motor cortex repetitive transcranial magnetic stimulation (M1-rTMS) and either motor cortex stimulation (MCS) or deep brain stimulation of the sensory thalamus (Vc-DBS), in patients suffering from central post-stroke pain (CPSP). A total of 32 CPSP patients will participate in a double-blind randomized crossover design, receiving both active and inactive stimulation. Assessments will include clinical scales for pain, function, quality of life, and depression, along with monitoring for adverse events. Additionally, functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be utilized to explore changes in pain brain circuitry and the effects of neuromodulation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with pharmacorefractory central post-stroke pain.
Not a fit: Patients with aphasia, uncontrolled seizures, or those who cannot undergo MRI or PET imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from central post-stroke pain who have not responded to conventional therapies.
How similar studies have performed: While there is limited evidence for the effectiveness of these neuromodulation techniques in CPSP, similar approaches in other neuropathic pain conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to provide voluntary written informed consent of the participant prior to any screening procedures 2. Male or female patients 3. Aged 18-70 years 4. Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in \<50% VAS reduction and/or intolerable side-effects) Exclusion Criteria: 1. Aphasia 2. Pregnancy or intention to become pregnant in the following year 3. Medical inoperability 4. Impossibility to temporarily withhold anticoagulation or anti-platelet medication 5. Impossibility to undergo MRI, fMRI and/or PET imaging 6. Complete destruction of the stimulation target region (M1 or Vc) 7. Uncontrolled seizures 8. Expected relocation in the following year.
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Philippe De Vloo, prof. dr.
- Email: neurochirurgie@uzleuven.be
- Phone: 016 344290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.