NCT03446378

Brief Summary

In this study, it is wondered whether cortical excitability level could predict/direct the use of transcranial direct current stimulation combined with physical therapy on upper limb rehabilitation of post stroke patients. Furthermore, the study aims to correlate the motor recovery with cortical excitability level. For this purpose, after basal evaluation, patients will be classified according motor function evaluated by Fugl Meyer in following categories: (ii) moderate: more than 19 points on Fulg Meyer (ii) severe: less than 19 points on Fulg Meyer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

February 8, 2018

Last Update Submit

May 4, 2020

Conditions

StrokeTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Fugl Meyer assesment of paretic upper limb motor function

    Fugl Meyer assesment 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, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points. Higher scores indicates better outcomes

    before 10 sessions, before 6 session and after 10 sessions - each session means 1 day

Secondary Outcomes (5)

  • Cortical excitability level

    before and after 10 sessions - each session means 1 day

  • Change from Motor acitivy log - 30

    before and after 10 sessions - each session means 1 day

  • Change from Functional independence measure

    before and after 10 sessions - each session means 1 day

  • Electroencephalography

    before and after 10 sessions - each session means 1 day

  • Changes on Patient Global Impression of Change Scale

    before the 6 session and after 10 sessions - each session means 1 day

Study Arms (3)

Anodal tDCS + physical therapy

EXPERIMENTAL

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 contralateral supraorbital region. 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: Anodal tDCSBehavioral: Physical therapy

Cathodal tDCS + physical therapy

EXPERIMENTAL

tDCS will be applied with duration of 20 minutes, intensity of 2 mA where cathodal electrode will be on the affected hemisphere and the anodal electrode, on the contralateral supraorbital region. 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

Behavioral: Physical therapyDevice: Cathodal tDCS

Sham tDCS + physical therapy

SHAM COMPARATOR

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 contralateral supraorbital region. 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 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

Behavioral: Physical therapyDevice: Sham tDCS

Interventions

Anodal tDCSDEVICE

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 questionnaire will be applied

Anodal tDCS + physical therapy
Physical therapyBEHAVIORAL

all patients will be submitted to a protocol of exercise with differents levels according with motor learing and neuroplasticity principles. All physical therapists were trained before the study.

Anodal tDCS + physical therapyCathodal tDCS + physical therapySham tDCS + physical therapy
Cathodal tDCSDEVICE

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 questionnaire will be applied

Cathodal tDCS + physical therapy
Sham tDCSDEVICE

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 questionnaire will be applied

Sham tDCS + physical therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
  • Chronic Stroke (\> 3 months)
  • Sensorimotor sequelae in an upper limb due to stroke
  • Score ≥ 18 at Folstein Mini Mental State Examination

You may not qualify if:

  • Prior neurological diseases
  • Multiple brain lesions
  • Metal implant in the skull and face
  • Pacemaker
  • History of seizures
  • Epilepsy
  • Pregnancy
  • Hemodynamic instability
  • Traumatic orthopedic injuries of upper limb that compromise the function
  • Altered medication for less than 3 months or who underwent botulinum toxin for less than 6 months
  • Performing physical therapy elsewhere during the period of intervention
  • Patients who do not present RMT in the healthy hemisphere.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco, Applied Neuroscience Laboratory

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current StimulationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled double-blind clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 26, 2018

Study Start

March 3, 2018

Primary Completion

September 1, 2018

Study Completion

March 1, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations

BR(1)