Transcranial Galvanic Stimulation After Stroke

NCT00407667 | Completed

• 1 other identifier: TraGAT
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 3

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

Keywords

hemiparesis; rehabilitation; upper limb rehabilitation; arm therapy

Outcome Measures

Primary Outcomes (1)

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

  45 min

Secondary Outcomes (1)

• Box&Block Test

  5 min

Study Arms (3)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

SHAM COMPARATOR

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

Interventions

transcranial galvanic stimulation DEVICE

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subacute stroke
• stroke interval 3 to 8 weeks
• severe upper limb paresis
• Fugl-Meyer \< 18

You may not qualify if:

• history of epilepsy
• antiepileptic, neuroleptic medication
• metal implants

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (3)

Charité, University Medicine Berlin, Medical Park Berlin

Berlin, 13507, Germany

Location

Klinik Bavaria

Kreischa, 09567, Germany

Location

Villa Melitta

Bolzano, 3600, Italy

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Hesse, MD

  Charité -University Medicine Berlin; Medical Park Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 21, 2011

Record last verified: 2006-11

Locations

DE (2); IT (1)