Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 excitationinhibition 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 100 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 cTBS70 RMT iTBS 2 conventional intensity priming iTBS 70 RMT cTBS70 RMT iTBS 3 nonpriming iTBS sham cTBS70 RMT iTBS and 4 sham stimulation sham cTBSsham 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 excitationinhibition 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
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 100 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 cTBS70 RMT iTBS 2 conventional intensity priming iTBS 70 RMT cTBS70 RMT iTBS 3 nonpriming iTBS sham cTBS70 RMT iTBS and 4 sham stimulation sham cTBSsham 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 excitationinhibition 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
Detailed Description:
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 excitationinhibition 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 100 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 cTBS70 RMT iTBS 2 conventional intensity priming iTBS 70 RMT cTBS70 RMT iTBS 3 nonpriming iTBS sham cTBS70 RMT iTBS and 4 sham stimulation sham cTBSsham 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 excitationinhibition 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
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 100 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 cTBS70 RMT iTBS 2 conventional intensity priming iTBS 70 RMT cTBS70 RMT iTBS 3 nonpriming iTBS sham cTBS70 RMT iTBS and 4 sham stimulation sham cTBSsham 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 excitationinhibition 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None