Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation of Stroke (RAICup) "RAICup"

Terminated

Phase 2 Results N/A

Trial Description

The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility at 3 months with remaining effect at one year, without significant adverse effect.

Detailed Description

Stroke survivors may be left with disability involving speech or residual arm or leg weakness. Despite spontaneous improvement on the weeks following stroke, the importance of final disability is unpredictable. If the core of the infarct is represented by dead neurons, the neurons from adjacent areas seem to be staggered and their lack of excitability has been correlated to a bad prognosis. Repetitive transcranial magnetic stimulation (rTMS) seems to be a promising technique since high frequency rTMS can increase excitability of the targeted neurons.
The aim of the study is to evaluate after 2 weeks of 20 min of rTMS each day: 1) the improvement of arm function and neurological and disability scales, immediately after the 2-week session, at one month, 3 months and evaluate the remnant effect at 12 months, 2) to correlate these scales to physiological parameters in order to assess the clinical modifications to the electrophysiological modifications, 3) to assert the safety of high frequency rTMS at the subacute phase of ischaemic stroke.

Trial Stopped: sponsor decision

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation Device
    Intervention Desc: MagPro x100 (MagVenture A/S, DANEMARK)
    ARM 1: Kind: Experimental
    Label: receive real rTMS
    Description: For real rTMS, pulses will be delivered at a frequency of 5 Hz for 6s with a 54s interval, with an intensity equal of 90% of the motor threshold as established at Baseline. 20-min real stimulation sessions will be administered 5 days a week for a period of 2 weeks
    ARM 2: Kind: Experimental
    Label: sham rTMS
    Description: For sham rTMS, procédures will be identical to those used for real rTMS with the exception that a placebo procedures will be used administered 5 days a week for a period of 2 weeks.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in the arm function in patients treated with rTMS as measured by the ARA (Action Research Arm) test at 3 months follow-up compared to the sham treated patients 3 months No
Secondary Improvement of hand function as measured by ARA test and Box and Block test at 2-week, 1 month, 3 months and 1 year follow-up 1 year No
Secondary Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth) 1 year No
Secondary Identify groups of good and bad responders in correlation to other excitability parameters and other parameters known to impede functional outcome (importance of the initial deficit, infarct volume, lesion on the CORTICO-spinal tract) 1 year No
Secondary Period before the patient is able to go back home 1 year No
Secondary Influence of the side of the stimulation on depression (Hamilton scale) 1 year Yes

Sponsors