Central Post-Stroke PainNCT07909954
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
A study testing High-dose accelerated intermittent theta burst stimulation (aiTBS) and Low-dose accelerated intermittent theta burst stimulation (aiTBS) in people with Central Post-Stroke Pain and Stroke, run by Duke University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Central Post-Stroke Pain, Stroke, Ischemic Stroke and Hemorrhagic Stroke
- What is being tested?
- High-dose accelerated intermittent theta burst stimulation (aiTBS) and Low-dose accelerated intermittent theta burst stimulation (aiTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Mar 2029
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of a co-morbid pain syndrome
- Documented seizure disorder before or after stroke
- Scalp wound or bone defect (i.e., craniotomy)
- Contraindications to MRI or rTMS (i.e., implanted metallic devices in the head, neck or chest)
- No changes in pain medications during the prior 4 weeks, and no intention to change pain medications during the study
- Significant change (1.2) in VAS between the two baseline visits to suggest instability of the CPSP
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Salman Ikramuddin contact
About this study
Official title: Accelerated Theta-Burst Stimulation for the Treatment of Refractory Central Post-Stroke Pain: A Pilot Trial
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.
- Being tested
- High-dose accelerated intermittent theta burst stimulation (aiTBS), Low-dose accelerated intermittent theta burst stimulation (aiTBS)
- Keywords
- Central Post-Stroke Pain, Transcranial Magnetic Stimulation, Neuromodulation, stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose accelerated intermittent theta burst stimulation (aiTBS)Device
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.
Low-dose accelerated intermittent theta burst stimulation (aiTBS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| High-dose aiTBS | Experimental | 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. Receives: Device: High-dose accelerated intermittent theta burst stimulation (aiTBS) |
| Low-dose aiTBS | Experimental | 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. Receives: Device: Low-dose accelerated intermittent theta burst stimulation (aiTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by the proportion of participants who can complete 80% of stimulation sessions
Measured: 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
Measured: From the time of stimulation (day 1) until end of stimulation (day 5)
Feasibility, as measured by consent rate of those screened
Measured: Baseline
Safety, as measured by the number of adverse events
Measured: 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").
Measured: Baseline, 7 days, and 90 days
Secondary outcomes (1)
Thalamo-cortical disconnection index (TCDI), derived from MRI
Measuring thalamo-cortical disconnection index (TCDI) as a potential biomarker to predict treatment response.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Salman Ikramuddin, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909954
- Sponsor's protocol ID
- Pro00120689
- Other IDs
- 26CDA1590369
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Theta-Burst Stimulation for the Treatment of Refractory Central Post-Stroke Pain: A Pilot Trial
- ClinicalTrials.gov ID
- NCT07909954
- Acronym / sponsor ID
- Pro00120689
- Keywords
- Central Post-Stroke Pain, Transcranial Magnetic Stimulation, Neuromodulation, stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 2 Nov 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose aiTBS | Experimental | Device: High-dose accelerated intermittent theta burst stimulation (aiTBS)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. |
| Low-dose aiTBS | Experimental | Device: Low-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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Diagnosis of a co-morbid pain syndrome
- Documented seizure disorder before or after stroke
- Scalp wound or bone defect (i.e., craniotomy)
- Contraindications to MRI or rTMS (i.e., implanted metallic devices in the head, neck or chest)
- No changes in pain medications during the prior 4 weeks, and no intention to change pain medications during the study
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 |
|---|---|---|
| High-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. | Device | High-dose aiTBS |
| 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 5 sessions per day over a 5-day treatment period. | Device | Low-dose aiTBS |
Primary outcome
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)
Time frame: Baseline, 7 days, and 90 days
The VAS consists of a scale from 0 ("no pain") to 10 ("worst possible pain").
1 secondary outcome
Thalamo-cortical disconnection index (TCDI), derived from MRI
Time frame: Baseline
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Salman Ikramuddin contact
Salman Ikramuddin principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing High-dose accelerated intermittent theta burst stimulation (aiTBS) and Low-dose accelerated intermittent theta burst stimulation (aiTBS) in people with Central Post-Stroke Pain and Stroke, run by Duke University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Duke Stroke Research Team (919-660-4131, strokeresearch@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. 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 2 Nov 2026; AzTrials last refreshed its copy on 2 Nov 2026.