search
Back to results

Transcranial Galvanic Stimulation After Stroke (TraGAT)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
transcranial galvanic stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring hemiparesis, rehabilitation, upper limb rehabilitation, arm therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité, University Medicine Berlin, Medical Park Berlin
  • Klinik Bavaria
  • Villa Melitta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Box&Block Test

Full Information

First Posted
December 1, 2006
Last Updated
March 18, 2011
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT00407667
Brief Title
Transcranial Galvanic Stimulation After Stroke
Acronym
TraGAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
hemiparesis, rehabilitation, upper limb rehabilitation, arm therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Arm Title
2
Arm Type
Experimental
Arm Description
patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Arm Title
3
Arm Type
Sham Comparator
Arm Description
patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track)
Intervention Type
Device
Intervention Name(s)
transcranial galvanic stimulation
Intervention Description
for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Limb Motor Score (0-66)
Time Frame
45 min
Secondary Outcome Measure Information:
Title
Box&Block Test
Time Frame
5 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Hesse, MD
Organizational Affiliation
Charité -University Medicine Berlin; Medical Park Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité, University Medicine Berlin, Medical Park Berlin
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Klinik Bavaria
City
Kreischa
ZIP/Postal Code
09567
Country
Germany
Facility Name
Villa Melitta
City
Bozen
ZIP/Postal Code
3600
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Transcranial Galvanic Stimulation After Stroke

We'll reach out to this number within 24 hrs