Menu
Recruiting NCT05613686

Theta Burst Stimulation for Motor Recovery

No phase Interventional Transcranial Magnetic Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Transcranial Magnetic Stimulation. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Fugl-Meyer Assessment [Time frame: 12 weeks post intervention]
Secondary outcome measures (8)
  • Medical Research Council (MRC) Scale for Muscle Strength [Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
  • National Institutes of Health Stroke Scale [Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
  • Barthel Index [Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
  • Modified Rankin Scale [Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
  • MEP [Time frame: 1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
  • Fugl-Meyer Assessment [Time frame: 1 week post intervention]
  • Fugl-Meyer Assessment [Time frame: 4 weeks post intervention]
  • Fugl-Meyer Assessment [Time frame: 24 weeks post intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

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 th PMID 31901449

Identifiers

NCT: NCT05613686 · 202204105DINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗