Transcranial Galvanic Stimulation After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: transcranial galvanic stimulation

• Registration Number: NCT00407667
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-11
• Study Start: 2006-12
• Study First Submitted: 2006-12-01
• Study First Submitted QC: 2006-12-01
• Study First Posted: 2006-12-05
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Last Update Submitted: 2011-03-18
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	transcranial galvanic stimulation	patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
2	transcranial galvanic stimulation	patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
3	transcranial galvanic stimulation	patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Limb Motor Score (0-66)	45 min

Secondary Outcome Measures

Name	Time	Method
Box&Block Test	5 min

Trial Locations

Locations (3)

Charité, University Medicine Berlin, Medical Park Berlin; 🇩🇪 Berlin, Germany

Villa Melitta; 🇮🇹 Bozen, Italy

Klinik Bavaria; 🇩🇪 Kreischa, Germany