Effects of Bihemispheric Transcranial Direct Current Stimulation on Motor Function in Stroke Patients

Stroke Clinical Trial

Official title:

The Effect of Bihemispheric Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839316
• Other study ID #: KA15/271
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Paresis
• Stroke
• Transcranial Direct Current Stimulation
• Upper Extremity Paresis

Intervention

Device:
• tDCS
A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).
• sham tDCS
For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation

Locations

Country	Name	City	State
Turkey	Baskent University Faculty of Medicine,Ankara Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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. — View 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. — View 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

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in upper extremity impairment	The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA.; The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.	Before treatment sessions begin and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment).
Secondary	Change in functionality	The Functional Independence Measure (FIM) is an 18-item seven level ordinal scale of physical, psychological and social function.The tool is used to assess a patient's level of functionality as well as change in patient status in response to rehabilitation or medical intervention. 13 of the 18 items of the FIM assess motor function and provide a 'motor score', the remaining five questions assess communication and social skills and provide a 'cognitive score' . Each item is scored from 1=complete dependence of task to 7=complete independence of task. The lowest possible attainable total score is 18 and the highest possible attainable total score is 126. The higher the score the higher the level of independence. When considering the subscores, the lowest possible attainable motor score is 13 and the highest is 91. The lowest possible attainable cognitive subscore is 5 and the highest is 35.	Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
Secondary	Change in motor activity	The Brunnstrom Stages of Stroke Recovery is a test that evaluates the motor development of stroke patients. In 1966, Signe Brunnstrom identified the stages of motor development observed in a large number of hemiplegic patients. In this staging, the hemiplegic upper extremity, lower extremity and hand are evaluated separately and the motor development of these three areas are staged from 1-6. The lowest stage according to this staging system is stage 1 (flask, no movement); the highest stage is stage 6 (normal motor function). Higher Brunnstrom stages indicate better motor development.	Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)