Clinical trial NCT03839316: Effects of Bihemispheric Transcranial Direct Current Stimulation on Motor Function in Stroke Patients
Official title: The Effect of Bihemispheric Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Transcranial Direct Current Stimulation
Keywords: Cortical stimulation
Motor function
Rehabilitation
Stroke
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The aim of the study is to evaluate and compare the effect of tDCS plus conventional physiotherapy and occupational therapy to sham tDCS plus conventional physiotherapy and occupational therapy on upper extremity motor function in patients with subacute stroke was aimed in our study.

32 patients will be randomly assigned to one of two groups in parallel for the duration of the study: bihemispheric tDCS (n:16), or sham tDCS (n:16). In addition to a conventional physiotherapy and occupational therapy program, bihemispheric tDCS application will be applied to one group and sham tDCS applied to the second group. A constant current stimulator(ZMI Electronics Limited,Taiwan,2012) will be used for the application of tDCS. In both groups, the tDCS application will be started simultaneously with the occupational therapy session and will last for thirty minutes.
Primary purpose: TREATMENT

Brief summary: Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Although there have been significant advances in stroke rehabilitation with these techniques and treatments, research on this subject is continuing. Recent studies have focused on non-invasive brain stimulation techniques. Transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) therapies, which are methods of non-invasive brain stimulation that may be effective on cerebral remodelling, aim to reestablish the disturbed balance between the anatomic areas of the brain seen in stroke patients.

The primary aim of this study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.

Detailed description: Motor impairment due to ischemic and hemorrhagic stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Recent developments include noninvasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The use of these tools is based on neurophysiologic studies demonstrating an imbalance of interhemispheric interactions which appears to interfere with the recovery process.

The model of interhemispheric imbalance provides a framework for developing hypotheses based on its 2 facets: 1) upregulating excitability of intact portions of the ipsilesional motor cortex and 2) downregulating excitability of the contralesional motor cortex to modulate its unrestrained inhibitory influence on ipsilesional regions. Studies to date have shown have shown the beneficial effects of tDCS on motor skills and motor learning.

Bihemispheric tDCS may potentiate the effects of anodal stimulation to the lesional hemisphere through additional modulation of interhemispheric interactions via cathodal stimulation to the contralesional motor cortex.

The primary aim of this prospective, randomized, sham controlled study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, female or male
2. Clinical evaluation consistent with hemiplegia
3. First time stroke with brain computerized tomography (CT) and / or magnetic resonance imaging (MRI) findings consistent with stroke
4. At least 3 months since stroke onset
5. Presence of a stable medical condition
6. Preserved cognitive function as determined by a mini mental state examination score of 23 and above

Exclusion Criteria:

1. Presence of a sensory aphasia
2. Presence of neglect syndrome
3. A history of epilepsy
4. Presence of a pacemaker
5. Previous history of stroke
6. History of previous cranial surgery
7. Presence of a brain tumour
8. Presence of an intracranial metallic implant
9. Marked hearing / visual impairment
10. Presence of severe spasticity (grade 3-4 according to the modified Ashworth scale)

Primary outcomes:
measure: Change in upper extremity impairment
timeFrame: Before treatment sessions begin and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment).
Secondary outcomes:
measure: Change in functionality
timeFrame: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
measure: Change in motor activity
timeFrame: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Medicine,Ankara Hospital
Study officials:
affiliation: Baskent University Faculty of Medicine
name: Seyhan Sozay, MD
role: STUDY_DIRECTOR
References:
citation: Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
citation: Tedesco Triccas L, Burridge JH, Hughes AM, Pickering RM, Desikan M, Rothwell JC, Verheyden G. Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. Clin Neurophysiol. 2016 Jan;127(1):946-955. doi: 10.1016/j.clinph.2015.04.067. Epub 2015 May 4.
citation: Elsner B, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for upper limb rehabilitation after stroke: future directions. J Neuroeng Rehabil. 2018 Nov 15;15(1):106. doi: 10.1186/s12984-018-0459-7.
citation: Chhatbar PY, Ramakrishnan V, Kautz S, George MS, Adams RJ, Feng W. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship. Brain Stimul. 2016 Jan-Feb;9(1):16-26. doi: 10.1016/j.brs.2015.09.002. Epub 2015 Sep 7.
citation: Fusco A, De Angelis D, Morone G, Maglione L, Paolucci T, Bragoni M, Venturiero V. The ABC of tDCS: Effects of Anodal, Bilateral and Cathodal Montages of Transcranial Direct Current Stimulation in Patients with Stroke-A Pilot Study. Stroke Res Treat. 2013;2013:837595. doi: 10.1155/2013/837595. Epub 2013 Jan 8.
citation: Hall KM, Hamilton BB, Gordon WA, Zasler ND. Characteristics and comparisons of functional assessment indices: Disability rating scale, functional independence measure and functional assessment measure. Journal of Head Trauma Rehabilitation 8(2):60-74, 1993
citation: Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.