Transcranial Galvanic Stimulation After Stroke

NCT ID: NCT00407667

Last Updated: 2011-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Group Type: EXPERIMENTAL

transcranial galvanic stimulation

Intervention Type: DEVICE

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

2

patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Group Type: EXPERIMENTAL

transcranial galvanic stimulation

Intervention Type: DEVICE

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

3

patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)

Group Type: SHAM_COMPARATOR

transcranial galvanic stimulation

Intervention Type: DEVICE

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

Interventions

transcranial galvanic stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charité - University Medicine Berlin

Principal Investigators

Stefan Hesse, MD

Role: PRINCIPAL_INVESTIGATOR

Charité -University Medicine Berlin; Medical Park Berlin

Locations

Charité, University Medicine Berlin, Medical Park Berlin

Berlin, , Germany

Klinik Bavaria

Kreischa, , Germany

Villa Melitta

Bolzano, , Italy

Countries

Germany; Italy

Other Identifiers

TraGAT

Identifier Type: -

Identifier Source: org_study_id