Clinical trial NCT04124172: Efficacy and Safety of rTMS Plus Rehabilitation for the Improvement of the Upper Extremity in Stroke (ERES)
Official title: Pilot Study to Evaluate the Efficacy and Safety of rTMS Associated With Rehabilitation for the Improvement of the Functionality of the Upper Extremity in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Arm Paralysis
Keywords: stroke
rTMS
upper limb rehabilitation
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized design (rTMS vs simulated stimulation before upper limb rehabilitation session) in patients with a single stroke (\< 6 months) and unilateral involvement with upper limb paresis (Fugl Meyer \> 22).Patients received 15 consecutive rTMS (real or not) plus rehabilitation. Clinical evaluation will be performed before, at the end and one month after the intervention. A neurophysiological exam will be performed before and after the intervention also.
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change in functionality of the upper limb measured in Fugl-Meyer (F-M) scale
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); one month after the last stimulation (limits 7 days before or after the exact data)
measure: Change in functionality of the upper limb measured in Block test
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); one month after the last stimulation (limits 7 days before or after the exact data)
Secondary outcomes:
measure: Changes in functionality of the upper limb measured in Action Research Arm Test (ARAT)
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); one month after the last stimulation (limits 7 days before or after the exact data)
measure: Changes in functionality of the upper limb measured in 9-Hole Peg Test (9-HPT)
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); one month after the last stimulation (limits 7 days before or after the exact data)
Other outcomes:
measure: Neurophysiological exam of cortical excitability: motor threshold collected in the first interoseus dorsal (FID) muscle in the both hands.
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
measure: Neurophysiological exam of cortical excitability: mesure MEPs average in the FID of 10 stimulus in the hot spot of bothsides at 120% of the threshold intensity.
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
measure: Neurophysiological exam of cortical excitability:mesure MEPs average after pair pulses in the FID of 10 stimulus in the hot spot of bothsides at 120% of the threshold intensity, preceded of infratreshold stimulus (80%)in 2, 6 and 10 milliseconds
timeFrame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
Locations:
Study officials:
affiliation: Institut Guttmann
name: Raúl Pelayo, Neurologist
role: PRINCIPAL_INVESTIGATOR
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