Intermittent Theta Burst Stimulation for lower limb recovery 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 · NCT07073235 · Data updated 2026-11-12
This trial tests whether intermittent Theta Burst Stimulation (iTBS) of the cerebellum, combined with physical therapy, can improve leg movement and walking in people with chronic stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (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 25, 2025 |
| Trial ID | NCT07073235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with chronic stroke more than 6 months ago who have residual hemiparesis but can ambulate at least at Functional Ambulation Category (FAC) ≥3 and can undergo MRI and TMS procedures are ideal candidates.
✕Probably not a fit
People with metal implants, a history of seizures, pregnancy, claustrophobia preventing MRI, severe cognitive impairment, untreated or unstable depression/anxiety, or other disabilities that prevent intensive physical therapy are unlikely to benefit or be eligible.
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 trial will compare active intermittent Theta Burst Stimulation (iTBS) targeted to the contralesional cerebellum with a sham iTBS control, followed immediately by 45 minutes of conventional physical therapy three times per week for five weeks (15 sessions total). The stimulator and neuronavigation (Magstim Rapid² with ANT Visor2™) will be used and motor evoked potentials will be recorded with EMG to monitor responses. Participants and clinical assessors will be blinded to active versus sham stimulation. Advanced neuroimaging will be performed before and after the intervention period to look for functional and structural brain network changes associated with recovery.
Why it matters
Potential benefit: If successful, the combined iTBS plus rehabilitation approach could enhance or speed recovery of leg strength and walking ability in people with chronic stroke when added to standard therapy.
How similar studies have gone: Previous small trials using TMS/iTBS for motor recovery—mainly for the upper limb—have shown promising but mixed results, and cerebellar iTBS for lower-limb recovery in chronic stroke is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 * Chronic stroke (\>6 months) * Residual hemiparesis FAC ≥3 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, 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.