Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- miniBest test
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Contralesional cerebellum iTBS and conventional rehabilitation
The experimental group will receive intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
Intervention: Intermittent Theta Burst Stimulation (Device)
Contralesional cerebellum sham-iTBS and conventional rehabilitation
The placebo group will get sham intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
Intervention: Sham Intermittent Theta Burst Stimulation (Device)
Outcomes
Primary Outcomes
miniBest test
Time Frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance.
miniBest test
Time Frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance.
Secondary Outcomes
- Fugl-Meyer Assessment - Lower Extremity(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Modified Ashworth Scale (MAS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Neuroflexor(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Lower Extremity Motor Coordination Test (LEMOCOT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- 6 minutes walk test(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Functional Ambulation Categories (FAC)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Falls Efficacy Scale Swedish version (FES-S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Walking impact scale (MSWS-12 S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Canadian Occupational Performance Measure(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Montreal Cognitive Assessment (MoCA)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Stroke Impact Scale (SIS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Motor Evoked Potentials (MEPs)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Resting state functional MRI (rs-fMRI)(At baseline and after completion of the 5 week intervention to assess changes.)
- Neuroflexor(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Fugl-Meyer Assessment - Lower Extremity(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Modified Ashworth Scale (MAS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Falls Efficacy Scale Swedish version (FES-S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Stroke Impact Scale (SIS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Lower Extremity Motor Coordination Test (LEMOCOT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- 6 minutes walk test(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Functional Ambulation Categories (FAC)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Walking impact scale (MSWS-12 S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Canadian Occupational Performance Measure(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Montreal Cognitive Assessment (MoCA)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Motor Evoked Potentials (MEPs)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Resting state functional MRI (rs-fMRI)(At baseline and after completion of the 5 week intervention to assess changes.)
- Diffusion Tensor Imaging (DTI)(At baseline and after completion of the 5 week intervention to assess changes)
Investigators
Susanne Palmcrantz
PhD, Associate Professor, Reg Physiotherapist
Danderyd Hospital