Theta Burst Stimulation for Motor Recovery

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613686
• Other study ID #: 202204105DINB
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2022
• Est. completion date: October 29, 2024

Study information

• Verified date: October 2022
• Source: National Taiwan University Hospital
• Contact: Meng Ting Lin, M.D.
• Phone: +886-2312-3456
• Email: b96401093[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 29, 2024
• Est. primary completion date: October 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcranial Magnetic Stimulation

Intervention

Device:
• repetitive transcranial magnetic stimulation
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jääskeläinen 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, Rektorová 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. Review. Erratum in: Clin Neurophysiol. 2020 May;131(5):1168-1169. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	12 weeks post intervention
Secondary	Medical Research Council (MRC) Scale for Muscle Strength	Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Secondary	National Institutes of Health Stroke Scale	National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Secondary	Barthel Index	Barthel Index, score 100-0. Higher scores indicate a better outcome.	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Secondary	Modified Rankin Scale	Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Secondary	MEP	motor evoked potential	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Secondary	Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	1 week post intervention
Secondary	Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	4 weeks post intervention
Secondary	Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	24 weeks post intervention