Transcranial Galvanic Stimulation After Stroke "TraGAT"

Completed

Phase N/A Results

Trial Description

Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.

Conditions

Interventions

  • Robot-assisted arm training Behavioral
    Intervention Desc: The wearable, portable neurorobotic device combines a lightweight, motorized elbow brace with a computerized system that detects electrical impulses (electromyographic, or "EMG," signals) from the muscles.
  • Transcranial direct current stimulation Device
    Other Names: tDCS
    Intervention Desc: Transcranial direct current stimulation (tDCS) is the application of weak electrical currents (1-2 mA) to modulate the activity of neurons in the brain.
  • Transcranial galvanic stimulation Device
    Intervention Desc: for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
    ARM 1: Kind: Experimental
    Label: 1
    Description: patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
    ARM 2: Kind: Experimental
    Label: 2
    Description: patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
    ARM 3: Kind: Experimental
    Label: 3
    Description: patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

Subjects will have tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Limb Motor Score (0-66)
Secondary Box&Block Test 5 min No

Sponsors