- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845595
Cortical Excitability Sequential Changes in Response to Transcranial Magnetic Stimulation Post Stroke
The Sequential Rate of Change in Cortical Excitability in Response to Transcranial Magnetic Stimulation in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dokki
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Giza, Dokki, Egypt, 11432
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Forty ischemic hemiparetic stroke patients aging between 50-65 years.
- Patients with first ever ischemic stroke in the territory of the middle cerebral artery (MCA) confirmed by physician with non-contrast computed tomographic (CT) or magnetic resonance imaging (MRI) scans of the brain.
- Mild to moderate motor impairment verified according to (National Institutes of Health Stroke Scale (NIHSS)-motor arm score of 1 to 15, and modified Ashworths Scale (MAS) (1 or 1+)
- Time from onset of symptoms 3 to 6 months.
- Stable vital signs with clear consciousness and proper cooperation with assessment and treatment.
- Successful measurement of the Active motor threshold (AMT) from the 'motor hot spot' of the contralesional and the ipsilesional primary motor cortex (M1) with the election of the contralateral first dorsal interosseous (FDI) muscle .
- The medical ethical committee from faculty of physical therapy, Cairo university approved the project of the study.
- All the patients or their families were given their written consent form.
Exclusion Criteria:
- Patients who underwent surgical management including intravascular surgery or administration of tissue plasminogen activator .
- Patients with aphasia or apparent cognitive deficits ( eg, hand apraxia, unilateral spatial neglect) , visual field deficits or any psychiatric disorders or disturbed consciousness.
- Patients with serious general complications requiring intensive medical management (eg, pneumonia severe internal carotid artery stenosis or bilateral cerebrovascular lesion, heart failure, urinary tract infection, or malnutrition state)
- severe chronic or neurological diseases ( eg, shoulder pain; joint deformity or complete paralysis of the affected upper limb) .
- Any contraindications for rTMS in the guidelines (eg, patients with metal within the brain, such as clips for aneurysms, patients with a cardiac pacemaker, pregnant women, or a history of seizures or epilepsy).
- Use of any drugs that could have an effect on cortical excitability (eg, Anti-epileptic drugs).
- Patients previously underwent any type of treatments using transcranial magnetic stimulation.
- Refusal to sign the informed consent or could not carry out training or cooperate with assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: (LF-rTMS) group
Patients in the study group were treated with the contralesional (LF-rTMS) once per day for 20 minutes, Daily, 5 sessions per week (Sunday to Thursday), for 2 consecutive weeks in addition to the conventional upper limb physical therapy interventions.
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The (LF-rTMS) (low frequency repetitive transcranial magnetic stimulation) group received 1-hertz (HZ) stimulation at 90% of motor threshold to the "hot spot" of the primary cerebral cortex, using a 70-mm figure- 8 coil and Magstim Rapid2 stimulator (Magstim Company, USA).
Contralesional 1 HZ *rTMS* applied over the primary motor area "hot spot" at 90% of Active motor threshold .
Each rTMS session consisted of 1,200pulses; lasting 20 minutes The optimal site of stimulation on the skull are known as the "hot spot" .
"Hot spots" were found by searching for loci that triggered maximum visible contraction in the contralateral first dorsal interosseous *FDI* muscle, while the patient is contracting his whole limb as much as possible .
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Active Comparator: Control group
Patients in the control group were treated with the conventional upper limb physical therapy interventions (40 minutes to 1 hour, daily, 5 times per week for two consecutive weeks )
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neurodevelopmental technique (NDT) ( including Bobath and Brunnstrom approaches , proprioceptor and exteroceptor stimulation for the weak and inhibition for the hyperactive muscle groups, proprioceptive neuromuscular facilitation (PNF) specific techniques, Approximation and weight bearing, placing technique).
Task-oriented training (moving, grasping and releasing bottles ,cups , small toys).
Active participation of the whole hemiparetic upper extremity in different motor task training with coordination and Bilateral arm training exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Sequential cortical excitability mean values
Time Frame: (cAMT) and (iAMT) findings were recorded 5 minutes after the execution of each treatment session for 10 therapeutic consecutive sessions , applied for each patient in both groups .
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Sequential cortical excitability mean values were detected by recording the sessional values of the contralesional Active Motor Threshold (cAMT) and the ipsilesional Active Motor Threshold (iAMT) for all patients in each group. Compare the sessional mean values of (cAMT and iAMT) between both groups , to detect the recommended minimal number of sessions that revealed highest significant difference in cortical excitability between both groups. Higher (cAMT) sessional values represent a better outcome , while Lower (iAMT) sessional values represent a better outcome . |
(cAMT) and (iAMT) findings were recorded 5 minutes after the execution of each treatment session for 10 therapeutic consecutive sessions , applied for each patient in both groups .
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Cortical excitability (post to pre treatment) mean difference
Time Frame: Pre-treatment values of (cAMT and iAMT) were measured at the enrollment date, while the post treatment values of (cAMT and iAMT) were measured 5 minutes after the execution of the last treatment session.
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Compare the post to pre treatment mean difference in (cAMT) and (iAMT) values between both groups. Post treatment findings were recorded in relation to the pretreatment findings,where the difference between both recordings could detect the progress level implemented by each group. Higher (cAMT and iAMT) post to pre treatment difference represent a better outcome. |
Pre-treatment values of (cAMT and iAMT) were measured at the enrollment date, while the post treatment values of (cAMT and iAMT) were measured 5 minutes after the execution of the last treatment session.
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Upper limb motor performance (post to pre treatment) mean difference
Time Frame: Pre-treatment scores of (FMA-UE and hand grip dynamometer) were measured at the enrollment date, while the post treatment values of (FMA-UE and hand grip dynamometer) were measured 10 minutes after the execution of the last treatment session.
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Compare the post to pre treatment mean change in (FMA-UE) and hand grip dynamometer scores between both groups.Post treatment findings were recorded in relation to the pre-treatment scores ,where the difference between both recordings could detect the progress level implemented by each group.
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Pre-treatment scores of (FMA-UE and hand grip dynamometer) were measured at the enrollment date, while the post treatment values of (FMA-UE and hand grip dynamometer) were measured 10 minutes after the execution of the last treatment session.
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Cortical excitability sequential mean rate of change
Time Frame: (cAMT) and (iAMT) values were recorded 5 minutes after the execution of each treatment session for 10 consecutive sessions , for each patient in both groups . (cAMT and iAMT) rate of change was calculated as the difference between 2 successive values.
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The sessional rate of change in the (cAMT) and (iAMT) measures in relation to the previous session was calculated. (cAMT) rate of change was measured as the difference in the values of two successive (cAMT) recordings sequentially throughout the 10 therapeutic consecutive sessions. (iAMT) rate of change was measured as the difference in the values of two successive (iAMT) recordings sequentially throughout the 10 therapeutic consecutive sessions. Compare the sequential rate of change of (cAMT and iAMT) between both groups, to detect the recommended maximum number of sessions that revealed highest significant difference in cortical excitability sequential rate of change between both groups. Higher ( cAMT and iAMT) rate of change represent a better outcome. |
(cAMT) and (iAMT) values were recorded 5 minutes after the execution of each treatment session for 10 consecutive sessions , for each patient in both groups . (cAMT and iAMT) rate of change was calculated as the difference between 2 successive values.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Moushera H. Darwish, PHD, Cairo University
- Study Director: Mohamed S. El-Tamawy, MD, Kasr El Aini Hospital
Publications and helpful links
General Publications
- Zhang L, Xing G, Shuai S, Guo Z, Chen H, McClure MA, Chen X, Mu Q. Low-Frequency Repetitive Transcranial Magnetic Stimulation for Stroke-Induced Upper Limb Motor Deficit: A Meta-Analysis. Neural Plast. 2017;2017:2758097. doi: 10.1155/2017/2758097. Epub 2017 Dec 21.
- Blesneag AV, Slavoaca DF, Popa L, Stan AD, Jemna N, Isai Moldovan F, Muresanu DF. Low-frequency rTMS in patients with subacute ischemic stroke: clinical evaluation of short and long-term outcomes and neurophysiological assessment of cortical excitability. J Med Life. 2015 Jul-Sep;8(3):378-87.
- Carey JR, Deng H, Gillick BT, Cassidy JM, Anderson DC, Zhang L, Thomas W. Serial treatments of primed low-frequency rTMS in stroke: characteristics of responders vs. nonresponders. Restor Neurol Neurosci. 2014;32(2):323-35. doi: 10.3233/RNN-130358.
- Di Lazzaro V, Ziemann U. The contribution of transcranial magnetic stimulation in the functional evaluation of microcircuits in human motor cortex. Front Neural Circuits. 2013 Feb 13;7:18. doi: 10.3389/fncir.2013.00018. eCollection 2013.
- Du J, Tian L, Liu W, Hu J, Xu G, Ma M, Fan X, Ye R, Jiang Y, Yin Q, Zhu W, Xiong Y, Yang F, Liu X. Effects of repetitive transcranial magnetic stimulation on motor recovery and motor cortex excitability in patients with stroke: a randomized controlled trial. Eur J Neurol. 2016 Nov;23(11):1666-1672. doi: 10.1111/ene.13105. Epub 2016 Jul 18.
- Graef P, Dadalt MLR, Rodrigues DAMDS, Stein C, Pagnussat AS. Transcranial magnetic stimulation combined with upper-limb training for improving function after stroke: A systematic review and meta-analysis. J Neurol Sci. 2016 Oct 15;369:149-158. doi: 10.1016/j.jns.2016.08.016. Epub 2016 Aug 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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