Effects of tDCS Combined With mCIMT or Mental Practice in Poststroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate systematically and controlled the effectiveness of mental
      practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment
      of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol
      of transcranial direct current stimulation(tDCS)that will maximize the effects of the
      practice of mental image and mCIMT. To this end, the subjects included will be submitted to
      12 therapy sessions with active or sham tDCS combined with at least one of the following
      techniques: conventional physiotherapy, mental practice technique or mCIMT
    

Detailed description: 
      Eighty-four patients chronic post-stroke will be recruited to participate in the study. After
      screening to check the eligibility criteria and giving informed consent, the patients will be
      randomized into seven distinct groups (12 per group). All the patients will be submitted to
      12 therapeutic sessions that will occur with a frequency of three times a week.

      Before, immediately after and 1 month after the beginning of the experimental sessions
      patients will be submitted to an evaluation at each moment will be applied: (i) Fugl- Meyer
      Scale, (ii) Motor Activity Log Scale, (iii ) Jebsen-Taylor hand functional test, (iv)
      Independence Functional Measure (v) Box-Block Test, (vi) Dynamometry and (vii) Berg Balance
      Scale.

      In experimental sessions, the subjects always receive physiotherapy treatment with
      conventional techniques, the protocol will follow the guidelines outlined in Clinical
      Practice Guideline for physical therapy in stroke patients with the Royal Dutch Society for
      Physical Therapy (2004). Besides physical therapy, the patient may be subjected to
      transcranial direct current stimulation (tDCS) associated with the techniques of modified
      constraint-induced movement therapy (mCIMT) or mental practice (MP).

      tDCS protocol During tDCS sessions, the patients will be seated in a comfortable chair with
      head and arm rests. Continuous direct current will be applied by clinical microcurrent
      stimulator (Soterix, USA) using a pair of saline-soaked surface sponge electrodes (surface 35
      cm2). For anodal and sham stimulation (the polarity refers always to the motor cortical
      electrode), the anode electrode will be placed over primary motor cortex (M1; EEG 10/20
      system) of the affected hemisphere and cathode above contralateral orbit. For cathodal tDCS,
      the cathode will be positioned over M1 of the non-affected hemisphere and the anode was
      placed above the contralateral orbit. For bi-hemispheric tDCS the anode electrode will be
      placed over M1 of the affected hemisphere and the cathode over the M1 of the healthy
      hemisphere. Transcranial direct current stimulation will be administered with a current
      strength of 1 mA for 13 (anodal/bi-hemispheric tDCS) or 9 min (cathodal tDCS). Sham tDCS will
      be performed by current flow for 30 s, a method shown to achieve a good level of blinding
      mCIMT protocol The modified CIMT consisted of (i) complete immobilization of the non-paretic
      upper limb and (ii) intensive training the paretic upper limb and will be administered by a
      trained therapist, who was not involved in the pre-post evaluations.

      Continuously for six hours daily over a period of four weeks, including weekend, all patients
      will be remained with complete immobilization of the non paretic upper limb. For this, an arm
      sling with the shoulder in adduction and internal rotation, elbow flexed at 90º, wrist and
      fingers in neutral position, made specifically for each patient will be used. They will be
      advised to use the restriction during their daily activities and instructed to remove it
      every hour for 10 minutes to perform stretching, which has been previously taught by the
      researchers to avoid functional deterioration caused by disuse. All muscle groups of the
      upper extremity will be stretched. A guide with instructions of the stretching will be
      distributed to patients. The patients will be instructed to take the immobilization on every
      day at same hour the tDCS sessions. In addition, the patients will be allowed to take the arm
      sling off during activities in which safety would be compromised, such as toileting,
      dressing, and bathing.

      For intensive training the paretic upper limb, the patients will attend a gross motor and
      fine motor activities program performed for 1 hour per day, three times per week. Each task
      was performed for 2-3 minutes and the rest interval between tasks will be determined for each
      subject in order to avoid fatigue and excessive tiredness. The tasks will be progressively
      adapted by increasing speed or accuracy to allow improvement of patient performance. All
      tasks will be done with subjects sitting on a chair with standard dimensions and performed on
      support table. During training sessions, the patients will remain with the non-paretic arm
      immobilized.

      Mental practice protocol Prior to experimental sessions, the mental capacity of subjects to
      learn the imagery techniques will be tested by the Kinesthetic and Visual Imagery
      Questionnaire and a chronometric test. The Kinesthetic and Visual Imagery Questionnaire is an
      imagery assessment tool comprised of 10 items, each scored on a five-point ordinal scale,
      including the image clarity (visual dimension) and the sensations intensity (kinesthetic
      dimension) of body movements. Each item describes an action: (i) neck flexion/extension, (ii)
      shoulder shrugging, (iii) forward trunk flexion, (iv) forward shoulder flexion, (v) elbow
      flexion, (vi) thumb to finger tips, (vii) knee extension, (viii) hip abduction, (ix) foot
      external rotation, and (x) foot tapping. Subjects physically execute each movement and
      immediately afterwards imagine performing the same movement. A score of 5 corresponds to the
      highest clarity/intensity, and a score of 1 corresponds to the lowest clarity/ intensity (for
      a review, see Malouin et al., 2007). The Kinesthetic and Visual Imagery Questionnaire scores
      allowed the researcher to assess each participant's abilities and decide whether the subject
      was a suitable candidate for MP. Comparing actual and imagined movement times, the
      chronometric test determined the motor imagery ability of participants.

      The mental practice will consist of motor imagination of tasks. These tasks will consist of
      action for the patient to imagine themselves, with the greatest wealth of detail possible,
      performing motor activities with the hemiparetic upper limb, such as the movement of the
      touching thumb on each other's toes hand, or even the movement of bringing a cup towards his
      mouth. The technique of mental practice will be applied at the same time of the tDCS.
    

Intervention name(s): tDCS
Intervention type(s): Other
Intervention description(s): tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application. In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability. Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other intervention name(s): non invasive brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Stroke; transcranial direct current stimulation; constraint-induced movement therapy; mental practice