An interventional study of High-dose accelerated intermittent theta burst stimulation (aiTBS) and Low-dose accelerated intermittent theta burst stimulation (aiTBS) in Central Post-Stroke Pain, Stroke and Ischemic Stroke and Hemorrhagic Stroke, sponsored by Duke University. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive high-dose accelerated intermittent theta burst stimulation consisting of 10 sessions per day (18,000 pulses/day) over 5 consecutive days targeting the ipsilesional motor cortex.
Device: High-dose accelerated intermittent theta burst stimulation (aiTBS)
Participants receive low-dose accelerated intermittent theta burst stimulation consisting of 5 sessions per day (9,000 pulses/day) over 5 consecutive days targeting the ipsilesional motor cortex.
Device: Low-dose accelerated intermittent theta burst stimulation (aiTBS)
Accelerated intermittent theta burst stimulation delivered using transcranial magnetic stimulation to the ipsilesional primary motor cortex. Each session delivers 1,800 pulses, with participants receiving 10 sessions per day over a 5-day treatment period.
Accelerated intermittent theta burst stimulation delivered using transcranial magnetic stimulation to the ipsilesional primary motor cortex. Each session delivers 1,800 pulses, with participants receiving 5 sessions per day over a 5-day treatment period.
Feasibility, as measured by the proportion of participants who can complete 80% of stimulation sessions
Time frame: From the time of stimulation (day 1) until end of stimulation (day 5)
Feasibility, as measured by proportion of participants who complete 80% of stimulation days
Time frame: From the time of stimulation (day 1) until end of stimulation (day 5)
Feasibility, as measured by consent rate of those screened
Time frame: Baseline
Safety, as measured by the number of adverse events
Time frame: Day 90
Pain as measured by Visual Analog Scale (VAS)
The VAS consists of a scale from 0 ("no pain") to 10 ("worst possible pain").
Time frame: Baseline, 7 days, and 90 days
Thalamo-cortical disconnection index (TCDI), derived from MRI
Measuring thalamo-cortical disconnection index (TCDI) as a potential biomarker to predict treatment response.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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