Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

Eligibility criteria

Qualifiers

hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,

FMA score of the upper extremity ≤42,

adequate language and cognitive function to perform at least a 1-step obey-command,

pre-stroke functional level of modified Rankin Scale (mRS) ≤1,

Disqualifiers

those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,

those with progressive of hemodynamically unstable medical conditions,

those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,

those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,

Trial design

Treatments tested in this trial

  • High-Frequency1
  • cTBS1
  • High-Frequency2
  • cTBS2
  • High-Frequency3
  • cTBS3

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Samsung Medical Center

Lead sponsor

National Research Foundation of Korea

Collaborator

Ministry of Food and Drug Safety, Korea

Collaborator

Seoul National University Hospital

Collaborator

Bucheon St. Mary's Hospital

Collaborator

Saint Vincent's Hospital, Korea

Collaborator

Severance Hospital

Collaborator

Kumoh National Institute of Technology

Collaborator

NEUROPHET

Collaborator