Transcranial Galvanic Stimulation After Stroke (TraGAT)

Charité University Medicine Berlin

Status: Completed

Conditions: Stroke

Treatments: Device: transcranial galvanic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00407667

TraGAT

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subacute stroke
• stroke interval 3 to 8 weeks
• severe upper limb paresis
• Fugl-Meyer < 18

Exclusion criteria

• history of epilepsy
• antiepileptic, neuroleptic medication
• metal implants

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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96 participants in 3 patient groups

1

Experimental group

Description:

patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Treatment:

Device: transcranial galvanic stimulation

2

Experimental group

Description:

patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Treatment:

Device: transcranial galvanic stimulation

3

Sham Comparator group

Description:

patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Treatment:

Device: transcranial galvanic stimulation