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
- 48
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment - Upper Extremity
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 upper 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 controlled 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 ipsilesional motor cortex 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 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
Arms & Interventions
Ipsilesional motor cortex iTBS and conventional rehabilitation
The experimental group will receive intermittent theta burst stimulation on the ipsilesional motor cortex followed by 45 minutes of conventional rehabilitation interventions involving the upper extremity led or instructed by a physiotherapist.
Intervention: Intermittent Theta Burst Stimulation (Device)
Ipsilesional motor cortex sham-iTBS and conventional rehabilitation
The placebo group will receive sham intermittent theta burst stimulation on the ipsilesional motor cortex 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
Fugl-Meyer Assessment - Upper Extremity
Time Frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
used to quantify recovery of sensorimotor function in the upper extremity after a stroke. It is a 63 item test scored on a 3-level ordinal scale. The score ranges from 0 to 126 points. A higher score indicates recovery of sensorimotor function.
Fugl-Meyer Assessment - Upper Extremity
Time Frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
used to quantify recovery of sensorimotor function in the upper extremity after a stroke. It is a 63 item test scored on a 3-level ordinal scale. The score ranges from 0 to 126 points. A higher score indicates recovery of sensorimotor function.
Secondary Outcomes
- Diffusion Tension Imaging (DTI)(At baseline and after completion of the 5 week intervention to assess changes.)
- Resting state functional MRI (rs-fMRI)(At baseline and after completion of the 5 week intervention to assess changes.)
- 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.)
- Box and Block Test (BBT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Action Research Arm Test (ARAT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Dextrain Manipulandum™(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.)
- 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.)
- Box and Block Test (BBT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Action Research Arm Test (ARAT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Dextrain Manipulandum™(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Hand-held Dynamometer/Grip Strength(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Purdue Pegboard Test (PPT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Visuomotor force tracking(At baseline and after completion of the 5 week intervention and at the 12 weeks follow up, to assess changes)
- Montreal Cognitive Assessment (MoCA)(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.)
- Stroke Impact Scale (SIS)(At baseline and after completion of the 5 week intervention and at the 12 weeks follow up, to assess changes)
- 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 Tension 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