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Completed

NCT Number: NCT00407667

Transcranial Galvanic Stimulation After Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité, University Medicine Berlin, Medical Park Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial galvanic stimulation

Device

for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin

Primary outcomes

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

    Time frame: 45 min

Secondary outcomes

  1. Box&Block Test

    Time frame: 5 min

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Acronym: TraGAT

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2006
Registry last updated
Mar 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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