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tDCS in Poststroke on Upper Limb Rehabilitation

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ClinicalTrials.gov Identifier: NCT02166619
Recruitment Status : Unknown
Verified May 2014 by Kátia Monte-Silva, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

Brief Summary:
In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.

Condition or disease Intervention/treatment Phase
Stroke Device: tDCS + physical therapy Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS + physical therapy
Firstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric tDCS will be applied with duration of 20 minutes, intensity of 2 mA where anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. After tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Device: tDCS + physical therapy

Bihemispheric tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability.

Other: Physical Therapy

Other Name: non invasive brain stimulation, neuroConn (Germany)

Sham Comparator: Sham tDCS + physical therapy
Firstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric sham tDCS will be applied. Anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off after 30 seconds. After bihemispheric sham tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Device: tDCS + physical therapy

Bihemispheric tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability.

Other: Physical Therapy

Other Name: non invasive brain stimulation, neuroConn (Germany)




Primary Outcome Measures :
  1. Change in Fugl-Meyer assessment of paretic upper limb motor function [ Time Frame: baseline, after sessions, 30 and 90 days ]
    Fugl-Meyer assessment is used to measure motor control recovery. It is a 226-point scoring system that includes the following sessions: range of motion, pain, sensation, motor function of upper and lower limbs, balance and coordination/velocity. We will apply only two sessions: upper limb motor function and coordination/velocity. These sessions totalize 66 points.The instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.


Secondary Outcome Measures :
  1. Change from Motor Activity Log-30 [ Time Frame: baseline, after sessions, 30 and 90 days ]
    MAL is a scripted, structured interview to measure real-world upper extremity function. It was developed to measure the effects of therapy on the most impaired arm following stroke. Consists of 30 activities of daily living such as using a towel, brushing teeth and picking up a glass. For a specified time period post-stroke, patients are asked about the extent of activity performance and how well it was performed by the most impaired arm. Response scale ranges from 0 (never used) to 5 (same as pre-stroke). Scores average for activity frequency comprises the Amount of use scale (AOU); the mean of scores for how well the activity was performed comprises Quality of movement (QOM). Ideally, ratings are obtained from patient and as well as the caregiver.


Other Outcome Measures:
  1. Change from Jebsen-Taylor Hand Function Test [ Time Frame: baseline, after sessions, 30 and 90 days ]
    Jebsen-Taylor Hand Function Test was designed to provide short, objective test of hand functions commonly used in daily living activities. Targeted patient population included adults with neurological and musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunction which may be appropriate. The test was developed to be used by health professionals working in restoration of hand function. It consists of seven items that includes a range of fine motor, weighted and unweighted hand function activities.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
  • Chronic Stroke (> 12 months)
  • Sensorimotor sequelae in an upper limb due to stroke
  • Score ≥ 18 at Folstein Mini Mental State Examination
  • Score ≥ 4 at Ashworth Scale
  • Minimal active wrist movement (flexion and extension)
  • At least one pinch movement

Exclusion Criteria:

  • Prior neurological diseases
  • Multiple brain lesions
  • Metal implant in the skull and face
  • Pacemaker
  • History of seizures
  • Epilepsy
  • Pregnancy
  • Hemodynamic instability
  • Performing physical therapy elsewhere during the period of intervention
  • Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
  • Traumatic or orthopedic lesion limiting the range of motion of upper limb

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166619


Contacts
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Contact: Kátia Monte-Silva, PhD +55 81 88631322 monte.silvakk@gmail.com
Contact: Déborah Marques, PT +55 81 97479444 deby.marques@gmail.com

Locations
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Brazil
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco Recruiting
Recife, PE, Brazil, 50670-900
Contact: Adriana Baltar, PT    +55 81 91296401    adrianabaltarmaciel@gmail.com   
Contact: Maíra Souza, PT    +55 81 89496886    mairasouza77@gmail.com   
Sub-Investigator: Déborah Marques, PT         
Sub-Investigator: Maíra Souza, PT         
Sub-Investigator: Adriana Ribeiro, MSc         
Sub-Investigator: Sérgio Rocha, MSc         
D'Or Institute for Research and Education (ID'Or) Recruiting
Rio de Janeiro, Brazil
Contact: Fernanda Moll, PhD       fernandanrn@hotmail.com   
Principal Investigator: Fernanda Moll, PhD         
University Center Augusto Mota (UNISUAM) Recruiting
Rio de Janeiro, Brazil
Contact: Érika Rodrigues, PhD    +55 21 9971244796    erikacrodrigues@gmail.com   
Contact: Laura Oliveira, PhD    +55 21 934844107    lauraoliveira.ft@gmail.com   
Sub-Investigator: Zaira Lima, PT         
Sub-Investigator: Camilla Polonini, PT         
Sub-Investigator: Érica Vianna, PT         
Sub-Investigator: Débora Silva         
Sub-Investigator: Carlos Horsczaruk         
Sponsors and Collaborators
Universidade Federal de Pernambuco
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Director: Kátia Monte-Silva, PhD Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

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Responsible Party: Kátia Monte-Silva, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02166619     History of Changes
Other Study ID Numbers: ChronicStroke_tDCS_rehab
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: May 2014
Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
Stroke
Rehabilitation
Electric stimulation therapy
Neuroplasticity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases