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

Guttmann Institute

Status: Unknown

Conditions: Stroke; Arm Paralysis

Treatments: Device: Real rTMS (Magstim); Device: Sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04124172

2018285

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a stroke (ischemic-hemorrhagic) that conditions a limitation unilateral (brachial monoparesis or hemiparesis) and presenting a moderate or mild deficit (motor score 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 older than 18 y.o.

Exclusion criteria

• Patients with epilepsy or those with devices will be excluded from the study in your body or metallic at the brain level, as well as patients with craniotomy without cranioplasty.
• Also excluded are all patients whose conditions prevent them from complying with the rehabilitation protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Real rTMS

Active Comparator group

Description:

rTMS (Magstim Super Rapid, Magstim Company, Whitland, Wales, UK) with eight-shaped coil (1 Hz, 1500 stimuli) in M1of the contralateral hemisphere to the lesion ("healthy side"). M1 is defined like the hot spot to elucidated a motor evoked potential in the Abductor Pollicis Brevis (APB) muscle of the contralateral hand. Intervention will be performed before one hour rehabilitation session of the upper limb according to our clinical protocol, completing 15 sessions.

Treatment:

Device: Real rTMS (Magstim)

Sham rTMS

Sham Comparator group

Description:

Sham rTMS (Magstim Super Rapid, Magstim Company, Whitland, Wales, UK) with eight-shaped coil (1 Hz, 1500 stimuli) in M1of the contralateral hemisphere to the lesion ("healthy side"). Investigators will make the simulation disconnecting the coil but keeping its position during the same time as the real one. Intervention will be performed before one hour rehabilitation session of the upper limb according to our clinical protocol, completing 15 sessions.

Treatment:

Device: Sham rTMS