Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Lower Extremity in Chronic Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanderyd Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18
Chronic stroke (>6 months)
Residual hemiparesis FAC ≥3
Disqualifiers
Metal implants
Epilepsy/seizures
Pregnancy
Claustrophobia (related to MRIs exams)
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Theta Burst Stimulation
DeviceiTBS 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
Sham Intermittent Theta Burst Stimulation
DeviceIt is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Contralesional cerebellum iTBS and conventional rehabilitationExperimental treatment 1 intervention
Group B: Contralesional cerebellum sham-iTBS and conventional rehabilitationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
miniBest test
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.
Time frame
At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.Secondary outcomes
1
Fugl-Meyer Assessment - Lower Extremity
used to quantify sensorimotor function recovery after a stroke. It is a 43 item test scored on a 3-level ordinal scale. The score ranges from 0 to 86 points. A higher score indicates higher sensorimotor recovery.
Time frame
At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.2
Modified Ashworth Scale (MAS)
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle).
Time frame
At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.3
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Time frame
At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.4
Lower Extremity Motor Coordination Test (LEMOCOT)
assesses motor coordination deficits after stroke. The LEMOCOT assesses how many times a participant can alternately touch a proximal and distal target with their big toe within 20 seconds. Higher scores indicate better motor coordination in the lower extremity.
Time frame
At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.Other outcomes
1
National Institutes of Health Stroke Scale (NIHSS)
quantifies stroke severity based on weighted evaluation findings. The total NIHSS score ranges from 0 to 42, with higher scores indicating more severe strokes, categorized as follows: minor stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and severe stroke (21-42).
Time frame
At baseline.2
Barthel Index (BI)
measures a person's ability to complete activities of daily living (ADL). Scores range from 0 to 100, categorized as follows: Total dependence (0-20), Severe dependence (21-60), Moderate dependence (61-90), Slight dependence (91-99), and Independence (100).
Time frame
At baseline.3
Theoretical Framework of Acceptability questionnaire
to assess the acceptability of healthcare interventions, based on the developed Theoretical Framework of Acceptability (TFA). It uses a 5-point Likert scale to assess acceptability of the intervention. Higher scores indicate higher acceptability.
Time frame
After completion of the 5 week intervention to assess acceptability.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Danderyd Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov