tDCS on Motor Rehabiliation of Post Stroke Patients
Condition: Stroke; Transcranial Direct Current Stimulation
MeSH terms: Stroke
Study type: Interventional

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.
    

Detailed description: 
      After given prior informed consent, volunteers will be classified and randomized using a
      website (randomization.com) by a non-involved researcher. At study beginning, volunteers will
      be evaluated through structured questionnaire. They will be submitted to the following
      evaluations: (i) Fugl-Meyer Scale; (ii) Motor Activity Log - 30; (iii) Functional
      independence measure; (iv) Patient Global Impression of Change Scale.

      tDCS - 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 excitabilityquestionnaire will be
      applied.

      Primary outcome measure Change in Fugl Meyer assesment of paretic upper limb motor function
      (time frame: baseline, before 6 session, after 10 sessions (10 days).

      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.

      Secondary outcome measures Cortical excitabilit level it will be evaluated through single
      pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia). Initially, rest motor
      threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor
      evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA).
      For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45
      degrees from the midline, will be placed over the right primary motor cortex of lesioned and
      non lesioned hemisphere (C3 and/or C4 - 10/20 System). After, motor evoked potential will be
      evaluet by 20 pulses firing with 120% of RMT.

      Other pre specified outcome measures Change from Motor acitivy log - 30 (time frame: before
      and after 10 sessions (10 days)) MAL is a scripetd , structured, interview to measure real
      wordl 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 teath and picking up a glass. For a specificied 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 form o (never used) to 5 (same as pre stroke). Scores
      average for activity comprises the amount os use scale: the mean of scores of how well the
      acitivy was performed comprises the quality of movement. Ideaaly, ratings are obtained and as
      well as caregiver.

      Functional independence measure is a questionanere used to evaluate the functional ability of
      the patient after the disease. The scale contains 18 items, divided in two subscales: motor
      and cogntion. The evaluated activites included eating dressins, bathing, transfer and others.
      Each item ranges from 7 (complete independe) to 1 (total dependence), higher scores indicate
      more independece.

      EEG Patients will perform an assessment of brain activity through the EEG. Initially,
      patients will be placed seated in a chair at 90cm in front of a computer. Then, the equipment
      will be assembled, the points according to the 10-20 marking system will be identified: Cz,
      C3, C4, F3, F4, P3, P4, Fz and Pz.

      The protocol will follow the sequence of six consecutive moments (1 minute each) to monitor
      the patient's brain activity through Neuro Spectrum software:

        1. 1st minute: REST: the patient will be relaxed, at rest, without any communication and
           with eyes open;

        2. 2nd minute: OBSERVE - the patient will observe the video of the movement hand to mouth;

        3. 3rd minute: EXECUTION - the patient will reproduce the movement of the video with
           healthy limb;

        4. 4th minute: IMAGINATION - the patient will imagine the previous movement;

        5. 5th minute: EXECUTION - the patient will reproduce the movement of the video with a
           paretic limb;

        6. 6th minute: IMAGINATION - the patient will imagine the previous movement; Changes on
           Patient Global Impression of Change Scale - (time frame: before 10 sessions, before 6
           session, after 10 sessions (10 days))

      The PGICS is a one-dimensional measure in which individuals rate their improvement associated
      with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
    

Intervention name(s): Anodal tDCS; Physical therapy; Cathodal tDCS; Sham tDCS
Intervention type(s): Device; Behavioral; Device; Device
Intervention description(s): 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; 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.; 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled double-blind clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment