Clinical trial NCT05613686: Theta Burst Stimulation for Motor Recovery
Official title: Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Detailed description: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.

This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Eligibility criteria: Inclusion Criteria:

* 1.Unilateral ischemic or hemorrhagic stroke
* 2.Stroke within 3 months
* 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
* 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
* 5.Patient could sit over 15 minutes
* 6.Age over 20

Exclusion Criteria:

* 1.Previous stroke, traumatic brain injury, brain tumor
* 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
* 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
* 4.Patients unable to cooperate the treatment
* 5.Pregnancy
* 6.Depression

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
measure: National Institutes of Health Stroke Scale
timeFrame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
measure: Barthel Index
timeFrame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
measure: Modified Rankin Scale
timeFrame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
measure: MEP
timeFrame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention
measure: Fugl-Meyer Assessment
timeFrame: 1 week post intervention
measure: Fugl-Meyer Assessment
timeFrame: 4 weeks post intervention
measure: Fugl-Meyer Assessment
timeFrame: 24 weeks post intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Meng Ting Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.