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

NCT03839316 | Completed

• 1 other identifier: KA15/271
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Upper Extremity Paresis; Transcranial Direct Current Stimulation

Keywords

Cortical stimulation; Motor function; Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in functionality

  Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)

• Change in motor activity

  Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)

Study Arms (2)

tDCS group

ACTIVE COMPARATOR

Sixteen stroke patient receiving bihemispheric tDCS in addition to a conventional physiotherapy (PT) and occupational therapy (OT) program for five consecutive days per week for a three week period (a total of fifteen sessions). The one hour long conventional PT sessions will include an upper extremity range of motion, strengthening and neurofacilitation exercise program. The one hour long OT sessions will include task specific exercises chosen according to the patient's functional status, including activities aimed at improving gross and fine motor function of the upper extremities. The tDCS application will be applied at the beginning of each OT session and will be continued for a total of thirty minutes at 2 mA.

Device: tDCS

Sham group

SHAM COMPARATOR

Sixteen stroke patient receiving a conventional PT and OT program and sham tDCS for 5 consecutive days per week for a 3 week period ( a total of 15 sessions). The one hour long conventional PT and OT sessions will be the same as in the tDCS group. For sham tDCS, electrode application and positioning will be the same as the intervention group and will be applied at the beginning of each OT session as previously described. The current will initially be increased up to 2 mA, so to provide the typical initial tingling sensation, and slowly decreased over 30 seconds and consequently switched off. The electrodes will be removed after a total of thirty minutes.

Device: sham tDCS

Interventions

tDCS DEVICE

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).

Also known as: Conventional physiotherapy and occupational therapy

tDCS group

sham tDCS DEVICE

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

Also known as: Conventional physiotherapy and occupational therapy

Sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Medicine,Ankara Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 21068427 BACKGROUND

• 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.

  PMID: 25998205 BACKGROUND

• 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.

  PMID: 30442158 BACKGROUND

• 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.

  PMID: 26433609 BACKGROUND

• 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.

  PMID: 23365790 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21164120 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcranial Direct Current Stimulation; Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Seyhan Sozay, MD

  Baskent University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical and rehabilitation medicine trainee

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: December 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 6 months following article publication
• Access Criteria: The data will be shared with researchers providing a methodologically sound proposal Proposals should be directed to drdilekalisar@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data will be accessible for a period of one year.

Locations

TU (1)