Universität zu Köln

Hensel, Lukas, Grefkes, Christian ORCID: 0000-0002-1656-720X, Tscherpel, Caroline, Ringmaier, Corinna, Kraus, Daria, Hamacher, Stefanie ORCID: 0000-0003-2158-9101, Volz, Lukas J. and Fink, Gereon R. ORCID: 0000-0002-8230-1856 (2019). Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial. BMJ Open, 9 (12). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

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Abstract

Introduction Intermittent theta burst stimulation (iTBS) applied to primary motor cortex (M1) has been shown to modulate both the excitability and connectivity of the motor system. A recent proof-of-principle study, based on a small group of hospitalised patients with acute ischemic stroke, suggested that iTBS applied to the ipsilesional M1 combined with physical therapy early after stroke can amplify motor recovery with lasting after effects. A randomised controlled clinical trial using a double-blind design is warranted to justify the implementation of iTBS-assisted motor rehabilitation in neurorehabilitation from an acute ischaemic stroke. Methods/design We investigate the effects of daily iTBS on early motor rehabilitation after stroke in an investigator-initiated, longitudinal randomised controlled trial. Patients (n=150) with hemiparesis receive either iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45 degrees). On 8 consecutive workdays, a 45 min arm-centred motor training follows the intervention . The relative grip strength, defined as the grip force ratios of the affected and unaffected hands, serves as the primary outcome parameter. Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1. Ethics and dissemination The study was approved by the Ethics Commission of the Medical Faculty, University of Cologne, Germany (reference number 15-343). Data will be disseminated through peer-reviewed publications and presentations at conferences. Study title: Theta-Burst Stimulation in Early Rehabilitation after Stroke (acronym: TheSiReS).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hensel, Lukas UNSPECIFIED UNSPECIFIED UNSPECIFIED Grefkes, Christian UNSPECIFIED orcid.org/0000-0002-1656-720X UNSPECIFIED Tscherpel, Caroline UNSPECIFIED UNSPECIFIED UNSPECIFIED Ringmaier, Corinna UNSPECIFIED UNSPECIFIED UNSPECIFIED Kraus, Daria UNSPECIFIED UNSPECIFIED UNSPECIFIED Hamacher, Stefanie UNSPECIFIED orcid.org/0000-0003-2158-9101 UNSPECIFIED Volz, Lukas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fink, Gereon R. UNSPECIFIED orcid.org/0000-0002-8230-1856 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-125074
DOI:	10.1136/bmjopen-2019-034088
Journal or Publication Title:	BMJ Open
Volume:	9
Number:	12
Date:	2019
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	2044-6055
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRANSCRANIAL MAGNETIC STIMULATION; MOTOR NETWORK CONNECTIVITY; NONINVASIVE BRAIN-STIMULATION; UPPER-LIMB RECOVERY; CORTICAL EXCITABILITY; DISABILITY; CORTEX; POSTSTROKE; SURVIVORS Multiple languages Medicine, General & Internal Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/12507