Priming Theta Burst Stimulation for Stroke: A Study of Intensity
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Hong Kong Polytechnic University
About this trial
Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation/inhibition in patients with stroke.
Hypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke.
Design and subjects: A randomized controlled trial involving 108 patients with chronic stroke.
Study instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG).
Interventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \[RMT\] continuous theta burst stimulation \[cTBS\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week.
Main outcome measures: Upper limb motor tests and levels of cortical excitation/inhibition measured by TMS-evoked EEG potentials.
Data analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral upper limb motor dysfunction caused by ischemic or hemorrhagic stroke, with stroke onset≥6 months. Diagnosis will be verified using discharge summary and radiological reports issued by Hospital Authority. Qualifying participants will undergo structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience (UBSN) at PolyU to further confirm their lesion location in the period of experimental participation.
Age between 18 and 80 years.
Residual upper limb functions between levels 2-7 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.
Capable of providing informed written consent.
Disqualifiers
any contraindications to TMS (screened by the safety checklist by Rossi(33)) and/or MRI (screened by the MRI safety checklist offered by UBSN [see supplement]).
Diagnosed with any concomitant neurological disease other than stroke.
signs of cognitive impairment, with a Montreal cognitive assessment score<21/22 out of 30 (34).
Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score > 2 (35).
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol
DeviceThis procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Low intensity priming intermittent theta burst stimulation (iTBS)Experimental treatment 1 intervention
Group B: Standard priming intermittent theta burst stimulation (iTBS)Experimental treatment 1 intervention
Group C: Nonpriming intermittent theta burst stimulation (iTBS)Active comparator 1 intervention
Group D: Sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb
Time frame
Baseline2
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb
Time frame
At 3 weeks3
The Fugl-Meyer Assessment-Upper Extremity Scores
The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb
Time frame
At one-monthSecondary outcomes
1
P30 amplitude in the TMS-evoked potential
TMS-evoked potential is a time-locked signal elicited by single TMS pulses delivered to the cortex. P30 means the positive peak appeared at 30 ms after stimulation. The amplitude of P30 is correlated with cortical excitability mediated by excitatory interneurons.
Time frame
Baseline2
P30 amplitude in the TMS-evoked potential
TMS-evoked potential is a time-locked signal elicited by single TMS pulses delivered to the cortex. P30 means the positive peak appeared at 30 ms after stimulation. The amplitude of P30 is correlated with cortical excitability mediated by excitatory interneurons.
Time frame
At 3 weeks3
P30 amplitude in the TMS-evoked potential
TMS-evoked potential is a time-locked signal elicited by single TMS pulses delivered to the cortex. P30 means the positive peak appeared at 30 ms after stimulation. The amplitude of P30 is correlated with cortical excitability mediated by excitatory interneurons.
Time frame
At one-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Tung Wah Hospital
Collaborator
Source ClinicalTrials.gov