Intermittent Theta Burst Stimulation (iTBS) to improve upper‑limb movement after chronic stroke
Official title: Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
Run by Danderyd Hospital · NCT07073248 · Data updated 2026-11-12
This study will test if brief non‑invasive brain stimulation (iTBS) applied to the affected motor cortex plus regular physical therapy can improve arm and hand movement in adults who had a stroke more than six months earlier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Danderyd Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | November 2025 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07073248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged over 18 who are at least six months post‑stroke with residual upper‑limb weakness (Fugl‑Meyer UE score >17) and who can safely undergo MRI and TMS procedures are ideal candidates.
✕Probably not a fit
People with metal implants, a history of seizures/epilepsy, pregnancy, severe cognitive impairment, untreated or unstable depression/anxiety, claustrophobia preventing MRI, or other disabilities preventing intensive physical therapy are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double‑blind controlled trial will assign chronic stroke patients to receive either real intermittent Theta Burst Stimulation (iTBS) to the ipsilesional motor cortex or a sham iTBS procedure, followed immediately by 45 minutes of conventional physical therapy three times per week for five weeks. iTBS sessions use 600 pulses over about 190 seconds at 80% of active motor threshold with neuronavigated TMS and MEP monitoring; assessors and participants are blinded to group assignment. Advanced neuroimaging is performed before and after the intervention period to look for functional and structural brain network changes associated with recovery. Clinical motor outcomes and imaging changes will be compared between groups to determine feasibility and potential therapeutic effects.
Why it matters
Potential benefit: If successful, adding iTBS to standard rehabilitation could produce better arm and hand motor recovery for people living with chronic stroke.
How similar studies have gone: Previous TMS and iTBS studies in chronic stroke have reported modest motor improvements in some patients but results are mixed and the approach remains investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 * Chronic stroke (\>6 months) * Residual hemiparesis FM-UE\>17 Exclusion Criteria: * Metal implants * Epilepsy/seizures * Pregnancy * Claustrophobia (related to MRIs exams) * Severe cognitive impairment * Untreated or unstable depression/anxiety * Other disabilities prohibiting intensive physical training
Where it's running
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Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288, Stockholm
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Susanne Palmcrantz, PhD, Associate Professor — Dep of Clinical Sciences, Karolinska Institutet
- Study coordinator: Susanne Palmcrantz, PhD, Associate Professor
- Email: susanne.palmcrantz@ki.se
- Phone: 004681235000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.