Intermittent Theta Burst Stimulation (iTBS) to improve upper‑limb movement after chronic stroke
Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
NA · Danderyd Hospital · NCT07073248
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danderyd Hospital (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07073248 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stockholm
- 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
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.
Conditions: Stroke, Hemiplegia, Hemiparesis After Stroke, Hand Functionality, Chronic Stroke Patients, stroke, iTBS, TMS