Theta Burst Stimulation for Motor Recovery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Transcranial Magnetic Stimulation
• Intervention / Treatment: Device: repetitive transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng Ting Lin, M.D.; Phone Number: 67048 +886-2312-3456; Email: b96401093@ntu.edu.tw
• Study Contact Backup: Name: Ming Yen Hsiao, M.D., PhD; Phone Number: 67316 +886-2312-3456; Email: myferrant@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Meng Ting Lin, M.D.; Phone Number: +886-2312-3456; Email: b96401093@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: contralateral 1Hz+ipsilateral iTBS 1; Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1	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.
Experimental: contralateral 1Hz+ipsilateral iTBS 2; Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2	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.
Active Comparator: contralateral 1Hz; Patients received contralateral 1 Hz and ipsilateral sham iTBS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Barthel Index	Barthel Index, score 100-0. Higher scores indicate a better outcome.	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
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
MEP	motor evoked potential	1 week, 4 weeks, 12 weeks and 24 weeks post intervention
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	1 week post intervention
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	4 weeks post intervention
Fugl-Meyer Assessment	Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.	24 weeks post intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Meng Ting Lin, M.D., The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Clin Neurophysiol. 2020 May;131(5):1168-1169.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2022
• Primary Completion (Anticipated): October 29, 2024
• Study Completion (Anticipated): October 29, 2024

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202204105DINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: will make further analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No