Descending pathways in motor control.
Roger N Lemon
https://pubmed.ncbi.nlm.nih.gov/18558853Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07073248
Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
Led by Danderyd Hospital · Updated on 2025-11-21
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Danderyd Hospital
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and practical use of a non-invasive brain stimulation technique called intermittent Theta Burst Stimulation (iTBS) for helping motor recovery of the upper limb in people with chronic stroke. The study also aims to understand how brain networks change structurally and functionally after this treatment. This clinical trial is randomized and controlled to compare iTBS with a sham version. Participants will be randomly assigned to one of two groups. The experimental group will receive iTBS targeted at the affected motor cortex using specialized neuronavigation equipment, followed by 45 minutes of conventional physical therapy focusing on upper limb rehabilitation. The control group will receive a sham iTBS that mimics the procedure without active stimulation, followed by similar physical therapy. The intervention occurs three times per week for five weeks, totaling 15 sessions. Throughout the study, participants will undergo advanced brain imaging before and after the intervention to observe neuroplastic changes. Various assessments will measure motor function, muscle tone, strength, cognitive function, and daily performance at baseline, after the 5-week intervention, and at 12 weeks follow-up. Safety and clinical outcomes will be closely monitored by blinded assessors, spanning from the start through the follow-up period.
CONDITIONS
Brief Title
Effects of Intermitted Theta Burst Stimulation (iTBS) on Motor Recovery of Upper Extremity in Chronic Stroke Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Chronic stroke lasting more than 6 months
- Residual hemiparesis with Fugl-Meyer Upper Extremity score greater than 17
You will not qualify if you...
- Presence of metal implants
- History of epilepsy or seizures
- Pregnancy
- Claustrophobia related to MRI exams
- Severe cognitive impairment
- Untreated or unstable depression or anxiety
- Other disabilities that prevent intensive physical training
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Treatment
Duration - 5 weeks
Participants receive intermittent theta burst stimulation (iTBS) or sham iTBS followed by 45 minutes of conventional physical therapy involving the upper or lower extremity, 3 times per week for 5 weeks.
15 intervention visits (in-person) over 5 weeks
Follow-up
Duration - 7 weeks
Participants undergo assessments to evaluate motor recovery and neuroplastic changes after the intervention period.
1 follow-up visit at 12 weeks post-baseline (in-person)
Trial Site Locations
Total: 1 location
1
Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288, Stockholm
Stockholm, Sweden
Actively Recruiting
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Research Team
S
Susanne Palmcrantz, PhD, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial.
Jack Jiaqi Zhang, Zhongfei Bai, Kenneth N K Fong
https://pubmed.ncbi.nlm.nih.gov/35317611Theta burst stimulation for enhancing upper extremity motor functions after stroke: a systematic review of clinical and mechanistic evidence.
Jack Jiaqi Zhang, Youxin Sui, Alexander T Sack...
https://pubmed.ncbi.nlm.nih.gov/38671584Theta burst stimulation: what role does it play in stroke rehabilitation? A systematic review of the existing evidence.
Tingting Jiang, Xiupan Wei, Mingzhu Wang...
https://pubmed.ncbi.nlm.nih.gov/38297193Timing of Repetitive Transcranial Magnetic Stimulation Onset for Upper Limb Function After Stroke: A Systematic Review and Meta-Analysis.
Eline C C van Lieshout, H Bart van der Worp, Johanna M A Visser-Meily...
https://pubmed.ncbi.nlm.nih.gov/31849827Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS).
Jean-Pascal Lefaucheur, Nathalie André-Obadia, Andrea Antal...
https://pubmed.ncbi.nlm.nih.gov/25034472Magnetic Strategies for Nervous System Control.
Michael G Christiansen, Alexander W Senko, Polina Anikeeva
https://pubmed.ncbi.nlm.nih.gov/30939100The Effect of Repetitive Transcranial Magnetic Stimulation on Lower-Limb Motor Ability in Stroke Patients: A Systematic Review.
Huiliu Fan, Yang Song, Xuanzhen Cen...
https://pubmed.ncbi.nlm.nih.gov/34539362