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Clinical Trials/NCT00407667
NCT00407667
Completed
Not Applicable

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

Charite University, Berlin, Germany3 sites in 2 countries96 target enrollmentDecember 2006
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Charite University, Berlin, Germany
Enrollment
96
Locations
3
Primary Endpoint
Fugl-Meyer Upper Limb Motor Score (0-66)
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
December 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fugl-Meyer Upper Limb Motor Score (0-66)

Time Frame: 45 min

Secondary Outcomes

  • Box&Block Test(5 min)

Study Sites (3)

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