Efficacy and Safety of rTMS Plus Rehabilitation for the Improvement of the Upper Extremity in Stroke (ERES)

Last updated: October 9, 2019
Sponsor: Institut Guttmann
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Cataplexy

Treatment

N/A

Clinical Study ID

NCT04124172
2018285
  • Ages 18-70
  • All Genders

Study Summary

The rehabilitation of the upper limb after a stroke is a challenge due to its complexity and the important cerebral representation of it, particularly of the hand. Repetitive transcranial magnetic stimulation (rTMS) is a tool that can broaden the effect of rehabilitation and thus appears to be observed in different studies performed in patients in chronic phase. However, there are little data on its usefulness before 6 months after the stroke. The variability in the presentation, the fact that it is a phase where the motor deficit of the upper limb coexists with other deficits and medical problems partly explain the lack of specific studies.

The investigators present here a preliminary study on the efficacy of rTMS associated with the rehabilitation program of the paretic upper extremity due to a stroke in comparison with sham rTMS. Patients (with moderate to mild involvement) will be randomly distributed in the two study groups and will be evaluated both clinically and neurophysiologically before and after the sessions to try to demonstrate if there is a positive effect in a safe manner.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a stroke (ischemic-hemorrhagic) that conditions a limitation unilateral (brachial monoparesis or hemiparesis) and presenting a moderate or mild deficit (motorscore on the FM scale ≥ 22 at the motor level of the upper extremity)

  • To participate in the study the patient must sign an informed consent and be olderthan 18 y.o.

Exclusion

Exclusion Criteria:

  • Patients with epilepsy or those with devices will be excluded from the study in yourbody or metallic at the brain level, as well as patients with craniotomy withoutcranioplasty.

  • Also excluded are all patients whose conditions prevent them from complying with therehabilitation protocol.

Study Design

Total Participants: 24
Study Start date:
October 15, 2019
Estimated Completion Date:
April 15, 2021