NCT07073235

Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Lower Extremity in Chronic Stroke Patients

Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of lower extremity in the chronic phase after stroke. It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.

Detailed description

In this randomized control trial (RCT) group A will receive iTBS while group B will receive sham iTBS. Both groups will directly after the intervention receive 45 minutes of conventional physical therapy 3 times per week for 5 weeks, a total of 15 interventions by a blinded physiotherapist. For the iTBS intervention a Magstim Rapid² stimulator will be used also equipped with a Cadwell Sierra Summit EMG system \[for motor evoked potential (MEP) measurements\] and an ANT Visor2™ neuronavigation system \[for navigated transcranial magnetic stimulation (TMS) interventions\]. The iTBS parameters that will be used are: 600 pulses under 190 seconds at 80 % of Active Motor Threshold (AMT). The contralesional cerebellum will be targeted. The participants and clinical assessors will be blinded to the intervention. All the patients will undergo advanced neuroimaging examinations before and after the intervention period. The exams will be then compared to identify neuroplastic changes in brain circuits.

Conditions

• Stroke
• Hemiparesis After Stroke
• Chronic Stroke Patients
• Hemiplegia
• Ambulatory Difficulty

Interventions

Type	Name	Description
DEVICE	Intermittent Theta Burst Stimulation	iTBS protocol: 600 pulses at 80% of AMT for 190 sec on the contralesional cerebellum, targeted with the support of a neuronavigational system, 15 sessions over a period of 5 weeks
DEVICE	Sham Intermittent Theta Burst Stimulation	It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation.

Timeline

• Start date: 2025-11-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-07-18
• Last updated: 2025-11-25

Locations

1 site across 1 country: Sweden