NCT07909954Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Accelerated Theta-Burst Stimulation for the Treatment of Refractory Central Post-Stroke Pain: A Pilot Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This pilot study aims to evaluate the feasibility, safety, and preliminary efficacy of accelerated intermittent theta burst stimulation (aiTBS) as a noninvasive neuromodulation treatment for individuals with severe, refractory central post-stroke pain (CPSP). Participants will be randomized to receive either a high-dose or low-dose aiTBS protocol, and outcomes will include pain intensity and imaging biomarkers to assess treatment response.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Duke University
- Diseases
- Stroke
- NCT number
- NCT07909954
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Nov 2026 to the primary completion date, 31 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No changes in pain medications during the prior 4 weeks, and no intention to change pain medications during the study
Other illness
- Diagnosis of a co-morbid pain syndrome
- Documented seizure disorder before or after stroke
Other
- Scalp wound or bone defect (i.e., craniotomy)
- Contraindications to MRI or rTMS (i.e., implanted metallic devices in the head, neck or chest)
- Significant change (1.2) in VAS between the two baseline visits to suggest instability of the CPSP
- Pregnancy
Who the study is looking for
- Age ≥ 21 years old of any sex and race
- Ischemic or hemorrhagic stroke affecting the thalamus ≥6 months from symptom onset
- Development of refractory neuropathic pain (biologically plausible pain with confirmed stroke lesion, ≥6 months symptom duration, visual analogue scale \[VAS\] ≥5, failed 2 medication trials of at least 3 months each
- The ability to provide consent
- Presence of CPSP as defined by pain distribution in a neuroanatomically plausible distribution, a history suggestive of stroke, an MRI confirming the stroke lesion, as well as negative or positive sensory signs. PAIN-DETECT score must be ≥13.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.