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

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ClinicalTrials.gov Identifier: NCT04124172
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Raúl Pelayo, Institut Guttmann

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.


Condition or disease Intervention/treatment Phase
Stroke Arm Paralysis Device: Real rTMS (Magstim) Device: Sham rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants received rTMS vs simulated stimulation without information of their status. Physical therapy and clinical evaluation will be carried out blindly with respect to the status of brain stimulation. Only the researcher who performs the rTMS knows the intervention condition.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Real rTMS
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.
Device: Real rTMS (Magstim)
See arm description

Sham Comparator: Sham rTMS
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.
Device: Sham rTMS
See arm description




Primary Outcome Measures :
  1. Change in functionality of the upper limb measured in Fugl-Meyer (F-M) scale [ Time Frame: 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) ]
    Changes in the measure in F-M scale (numeric, *arm strength subscale*): FUGL-MEYER ASSESSMENT UPPER EXTREMITY (FMA-UE) (Fugl-Meyer et al., Scand J Rehabil Med 1975), using the motor function subscore (0 to 66, more functionality with high score)

  2. Change in functionality of the upper limb measured in Block test [ Time Frame: 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) ]
    Changes in the measure in Box and Block test (numeric, *total scale*) BOX AND BLOCKS TEST (Mathiowetz et al, Am J Occup Ther 1985) The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately. Maximum 150 blocks


Secondary Outcome Measures :
  1. Changes in functionality of the upper limb measured in Action Research Arm Test (ARAT) [ Time Frame: 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) ]
    Changes in the measure in ARAT (numeric, *total scale*) ACTION RESEARCH ARM TEST (Lyle RC, Int J Rehabil Res 1981) Score from 0 to 57 (better function with high score)

  2. Changes in functionality of the upper limb measured in 9-Hole Peg Test (9-HPT) [ Time Frame: 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) ]
    Changes in the measure in 9-HPT (time, seconds *total scale*) NINE HOLE PEG TEST (Mathiowetz et al, Occup Therap J Resaerach 1985) Time in second to perform the whole test will be recordered (better with less time)


Other Outcome Measures:
  1. Neurophysiological exam of cortical excitability: motor threshold collected in the first interoseus dorsal (FID) muscle in the both hands. [ Time Frame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); ]
    Motor threshold, mesured in percentage (%): Defined as the minimum stimulation intensity that can produce a motor output (MEP). Fifty microvolts (microV) MEP in 5 of 10 stimulus will be considered. The investigators will use a TMS sitimulation with a focal coil above the scalp in both sides

  2. 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. [ Time Frame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); ]
    MEP will be mesured in microV. The investigators will use a TMS sitimulation with a focal coil above the scalp in both sides.

  3. 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 [ Time Frame: Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day); ]
    Collected the MEP average 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 to study short interval intracortical inhibition (SICI) and short interval intracortical facilitation (SICF). The investigators will use a TMS sitimulation with a focal coil above the scalp in both sides.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124172


Contacts
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Contact: Raúl Pelayo, Neurologist +34 934977700 rpelayo@guttmann.com

Sponsors and Collaborators
Institut Guttmann
Investigators
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Principal Investigator: Raúl Pelayo, Neurologist Institut Guttmann
  Study Documents (Full-Text)

Documents provided by Raúl Pelayo, Institut Guttmann:

Additional Information:
Publications of Results:

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Responsible Party: Raúl Pelayo, MD, PhD, Institut Guttmann
ClinicalTrials.gov Identifier: NCT04124172     History of Changes
Other Study ID Numbers: 2018285
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Raúl Pelayo, Institut Guttmann:
stroke
rTMS
upper limb rehabilitation
Additional relevant MeSH terms:
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Stroke
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms