Transcranial Galvanic Stimulation After Stroke (TraGAT)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00407667
First received: December 1, 2006
Last updated: March 18, 2011
Last verified: November 2006
  Purpose

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.


Condition Intervention
Stroke
Device: transcranial galvanic stimulation

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Fugl-Meyer Upper Limb Motor Score (0-66) [ Time Frame: 45 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Box&Block Test [ Time Frame: 5 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Device: transcranial galvanic stimulation
for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
Experimental: 2
patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Device: transcranial galvanic stimulation
for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
Sham Comparator: 3
patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Device: transcranial galvanic stimulation
for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407667

Locations
Germany
Charité, University Medicine Berlin, Medical Park Berlin
Berlin, Germany, 13507
Klinik Bavaria
Kreischa, Germany, 09567
Italy
Villa Melitta
Bozen, Italy, 3600
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Stefan Hesse, MD Charité -University Medicine Berlin; Medical Park Berlin
  More Information

No publications provided

Responsible Party: TraGAT, Charité - University Medicine Berlin
ClinicalTrials.gov Identifier: NCT00407667     History of Changes
Other Study ID Numbers: TraGAT
Study First Received: December 1, 2006
Last Updated: March 18, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
hemiparesis
rehabilitation
upper limb rehabilitation
arm therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014