NCT05613686

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

October 30, 2022

Last Update Submit

August 16, 2024

Conditions

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment

    Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.

    12 weeks post intervention

Secondary Outcomes (8)

  • Medical Research Council (MRC) Scale for Muscle Strength

    1 week, 4 weeks, 12 weeks and 24 weeks post intervention

  • National Institutes of Health Stroke Scale

    1 week, 4 weeks, 12 weeks and 24 weeks post intervention

  • Barthel Index

    1 week, 4 weeks, 12 weeks and 24 weeks post intervention

  • Modified Rankin Scale

    1 week, 4 weeks, 12 weeks and 24 weeks post intervention

  • MEP

    1 week, 4 weeks, 12 weeks and 24 weeks post intervention

  • +3 more secondary outcomes

Study Arms (3)

contralateral 1Hz+ipsilateral iTBS 1

EXPERIMENTAL

Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1

Device: repetitive transcranial magnetic stimulation

contralateral 1Hz+ipsilateral iTBS 2

EXPERIMENTAL

Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2

Device: repetitive transcranial magnetic stimulation

contralateral 1Hz

ACTIVE COMPARATOR

Patients received contralateral 1 Hz and ipsilateral sham iTBS

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulationDEVICE

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.

contralateral 1Hzcontralateral 1Hz+ipsilateral iTBS 1contralateral 1Hz+ipsilateral iTBS 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous stroke, traumatic brain injury, brain tumor
  • With central nervous system disease (spinal cord injury, Parkinson's disease)
  • Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
  • Patients unable to cooperate the treatment
  • Pregnancy
  • Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31901449BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Meng Ting Lin, M.D.

    The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Ting Lin, M.D.

CONTACT

+886-2312-3456b96401093@ntu.edu.tw

Ming Yen Hsiao, M.D., PhD

CONTACT

+886-2312-3456myferrant@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 14, 2022

Study Start

October 29, 2022

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

will make further analysis

Locations

TW(1)