Transcranial Galvanic Stimulation After Stroke

Stroke Clinical Trial

— TraGAT  

Official title:

Transcranial Direct Current Stimulation (tDCS) of the Lesioned or Non-lesioned Hemisphere Plus Computer-assisted Arm Trainer: a Randomized, Placebo-controlled Double-blind Multi-centre Study in Patients With Severe Arm Paresis Early After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407667
• Other study ID #: TraGAT
• Status: Completed
• Phase: N/A
• First received: December 1, 2006
• Last updated: March 18, 2011
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: November 2006
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• transcranial galvanic stimulation
for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin

Locations

Country	Name	City	State
Germany	Charité, University Medicine Berlin, Medical Park Berlin	Berlin
Germany	Klinik Bavaria	Kreischa
Italy	Villa Melitta	Bozen

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Limb Motor Score (0-66)		45 min	No
Secondary	Box&Block Test		5 min	No