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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124172
• Other study ID #: 2018285
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: October 2019
• Source: Institut Guttmann
• Contact: Raúl Pelayo, Neurologist
• Phone: +34 934977700
• Email: rpelayo[@]guttmann.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arm Paralysis
• Paralysis
• Stroke

Intervention

Device:
• Real rTMS (Magstim)
See arm description
• Sham rTMS
See arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Guttmann

References & Publications (16)

Ameli M, Grefkes C, Kemper F, Riegg FP, Rehme AK, Karbe H, Fink GR, Nowak DA. Differential effects of high-frequency repetitive transcranial magnetic stimulation over ipsilesional primary motor cortex in cortical and subcortical middle cerebral artery str — View Citation

Avenanti A, Coccia M, Ladavas E, Provinciali L, Ceravolo MG. Low-frequency rTMS promotes use-dependent motor plasticity in chronic stroke: a randomized trial. Neurology. 2012 Jan 24;78(4):256-64. doi: 10.1212/WNL.0b013e3182436558. Epub 2012 Jan 11. — View Citation

Claflin ES, Krishnan C, Khot SP. Emerging treatments for motor rehabilitation after stroke. Neurohospitalist. 2015 Apr;5(2):77-88. doi: 10.1177/1941874414561023. — View Citation

Donnan GA, Davis SM. Breaking the 3 h barrier for treatment of acute ischaemic stroke. Lancet Neurol. 2008 Nov;7(11):981-2. doi: 10.1016/S1474-4422(08)70230-8. — View Citation

Emara T, El Nahas N, Elkader HA, Ashour S, El Etrebi A. MRI can Predict the Response to Therapeutic Repetitive Transcranial Magnetic Stimulation (rTMS) in Stroke Patients. J Vasc Interv Neurol. 2009 Apr;2(2):163-8. — View Citation

Emara TH, Moustafa RR, Elnahas NM, Elganzoury AM, Abdo TA, Mohamed SA, Eletribi MA. Repetitive transcranial magnetic stimulation at 1Hz and 5Hz produces sustained improvement in motor function and disability after ischaemic stroke. Eur J Neurol. 2010 Sep; — View Citation

Khedr EM, Etraby AE, Hemeda M, Nasef AM, Razek AA. Long-term effect of repetitive transcranial magnetic stimulation on motor function recovery after acute ischemic stroke. Acta Neurol Scand. 2010 Jan;121(1):30-7. doi: 10.1111/j.1600-0404.2009.01195.x. Epu — View Citation

Kwakkel G, Kollen BJ, Wagenaar RC. Long term effects of intensity of upper and lower limb training after stroke: a randomised trial. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):473-9. — View Citation

Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002 Jul;33(7):1840-4. — View Citation

Lefaucheur JP, André-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jääskeläinen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, P — View Citation

Reis J, Robertson E, Krakauer JW, Rothwell J, Marshall L, Gerloff C, Wassermann E, Pascual-Leone A, Hummel F, Celnik PA, Classen J, Floel A, Ziemann U, Paulus W, Siebner HR, Born J, Cohen LG. Consensus: "Can tDCS and TMS enhance motor learning and memory — View Citation

Sasaki N, Mizutani S, Kakuda W, Abo M. Comparison of the effects of high- and low-frequency repetitive transcranial magnetic stimulation on upper limb hemiparesis in the early phase of stroke. J Stroke Cerebrovasc Dis. 2013 May;22(4):413-8. doi: 10.1016/j — View Citation

Seniów J, Bilik M, Lesniak M, Waldowski K, Iwanski S, Czlonkowska A. Transcranial magnetic stimulation combined with physiotherapy in rehabilitation of poststroke hemiparesis: a randomized, double-blind, placebo-controlled study. Neurorehabil Neural Repai — View Citation

Takeuchi N, Oouchida Y, Izumi S. Motor control and neural plasticity through interhemispheric interactions. Neural Plast. 2012;2012:823285. doi: 10.1155/2012/823285. Epub 2012 Dec 26. Review. — View Citation

Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophy — View Citation

Zheng CJ, Liao WJ, Xia WG. Effect of combined low-frequency repetitive transcranial magnetic stimulation and virtual reality training on upper limb function in subacute stroke: a double-blind randomized controlled trail. J Huazhong Univ Sci Technolog Med — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurophysiological exam of cortical excitability: motor threshold collected in the first interoseus dorsal (FID) muscle in the both hands.	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	Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
Other	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.	MEP will be mesured in microV. The investigators will use a TMS sitimulation with a focal coil above the scalp in both sides.	Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
Other	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	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.	Before (during 7 days before the 1st stimulation day); at the end (during 7 days after the 15th stimulation day);
Primary	Change in functionality of the upper limb measured in Fugl-Meyer (F-M) scale	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)	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)
Primary	Change in functionality of the upper limb measured in Block test	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	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	Changes in functionality of the upper limb measured in Action Research Arm Test (ARAT)	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)	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	Changes in functionality of the upper limb measured in 9-Hole Peg Test (9-HPT)	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)	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)

External Links

•   Corporative web of Guttmann Institute