Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05613686
Other study ID # 202204105DINB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04927364 - Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder N/A
Recruiting NCT05973019 - rTMS Improves Functions in Spinocerebellar Ataxia N/A
Recruiting NCT06193278 - Individual Neuromodulation for PDS N/A
Completed NCT05074524 - Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings N/A
Recruiting NCT05889117 - Brain Stimulation for Concussion N/A
Recruiting NCT03974659 - Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients N/A
Completed NCT04014491 - The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome N/A
Recruiting NCT05914038 - Individualized rTMS for Motor Recovery in Stroke Patients N/A
Recruiting NCT06084455 - TMS-evoked Potentials During Aerobic Exercise N/A
Completed NCT05566444 - TMS-evoked Potentials During Heat Pain N/A
Enrolling by invitation NCT04313530 - TMS Treatment in Multiple System Atrophy With Fatigue N/A
Completed NCT04209309 - Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal N/A
Terminated NCT04486222 - Accelerated Bilateral rTMS on Geriatric Depression N/A
Recruiting NCT05192759 - Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait N/A
Recruiting NCT05467657 - Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke N/A
Recruiting NCT05896332 - rTMS in Older Adults With MCI and AUD Phase 1
Recruiting NCT04727177 - Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia Early Phase 1
Recruiting NCT04906603 - Theta Burst Stimulation for Headaches After Traumatic Brain Injury N/A
Recruiting NCT03590327 - Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment N/A
Recruiting NCT05843240 - Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke N/A