Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation "NTMSR"

Completed

Phase 4 Results N/A

Trial Description

The aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol.

Detailed Description

Stroke is the main cause of long-term disability among adults. Disability following stroke results in significant impairment of patients quality of life. There was a lot of investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional therapy in stroke rehabilitation. In this researches uses different protocols and patient's categories: high-frequency, low-frequency, etc. Using method of navigation transcranial magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess effectiveness of therapy and forming prognosis.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Device
    Other Names: TMS
    Intervention Desc: Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
    ARM 1: Kind: Experimental
    Label: Low-frequency stimulation
    Description: Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
    ARM 2: Kind: Experimental
    Label: High frequency stimulation
    Description: Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere
    ARM 3: Kind: Experimental
    Label: Sham stimulation
    Description: Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)
    ARM 4: Kind: Experimental
    Label: Both hemispheric stimulation
    Description: Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI up to 20 days Yes
Primary The emergence of epileptic seizure up to 20 days Yes
Secondary Evaluation of the clinical condition of the patient up to 20 days No

Sponsors