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tDCS and Speech Therapy to Improve Aphasia (MP-LOGA)

Primary Purpose

Aphasia, Global, Stroke, Transcranial Direct Current Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS + speech therapy
Sponsored by
Medical Park AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Global

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first time stroke (ischemic or hemorrhagic), either with a total or partial anterior circulation stroke according to the Bamford classification
  • stroke interval 10-45 days
  • moderate or severe aphasia, i.e. Goodglass-Kaplan-Communication-Scale (GKS, 0,1 or 2)
  • native speaker - german
  • age 18-90

Exclusion Criteria:

  • other neurological diseases affecting the CNS
  • known history of epileptic fits, except for an immediate fit
  • signs in the EEG of increased cortical excitability
  • patients with hemicraniectomy
  • fluent aphasia, i.e. GKS 3,4 or 5
  • speech apraxia
  • reduced sensibility of the scalp
  • previously radiated scalp
  • metallic parts or implants in the brain
  • participation in other interventional studies

Sites / Locations

  • Medical Park Berlin HumboldtmuehleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

verum-tDCS

sham-tDCS

Arm Description

verum-tDCS+ speech therapy

sham-tDCS + speech therapy

Outcomes

Primary Outcome Measures

Goodglass-Kaplan communication scale (GKS, 0-5)
the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5.
Aphasia Check-list (ACL, 0-148)
a german tool to assess language (analogous to the Aachener Aphasie Test). it measures a) colour-figure test, b) word generation and c) single speech domains

Secondary Outcome Measures

Aphasic depression rating scale (ADRS, 0-32)
rates the depression in patients with aphasia
Alterskonzentrationstest (AKT, 0-35)
assesses the concentration and vigilance of elderly people with stroke
Barthel-Index (BI,0-100)
evaluates the activities of daily living in patients suffering from stroke
Rivermead Motor Assessment - Arm (RMA, 0-15)
assesses the motor control of the upper extremity in patients with stroke

Full Information

First Posted
March 11, 2015
Last Updated
September 12, 2016
Sponsor
Medical Park AG
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1. Study Identification

Unique Protocol Identification Number
NCT02395874
Brief Title
tDCS and Speech Therapy to Improve Aphasia
Acronym
MP-LOGA
Official Title
MP-LoGa: Bi-hemispheral Transcranial Direct Current Stimulation to Improve the Severe Aphasia in Subacute Stroke Patients: a Randomized, Placebo-controlled, Double Blinded Multi-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Park AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients will be randomized by a computer-generated lot. Assessment will be performed at study onset, after six weeks at the end of the specific intervention and 4 months after stroke onset for follow-up.
Detailed Description
Approximately 25% of all patients after stroke suffer from aphasia. The aphasia could be so severe, that the patient cannot produce any words at all, and so the communication ability is rather poor. In that case speech therapy is the most common therapy, but the functional outcome for the patient is often not sufficiently. The transcranial direct current stimulation (tDCS) might improve the outcome of speech therapy in patients with severe aphasia. The patients will be randomized either to verum stimulation (group A) or sham stimulation (group B). In group A they will receive every workday for 6 weeks 20min of tDCS with 2 mA in combination with a 30 min speech therapy. In group B they will receive every workday for 6 weeks 20min of tDCS with 0 mA in combination with a 30 min speech therapy. The anodal electrode will be placed in case of a total anterior circulation stroke on the homologous speech area on the right hemisphere and in case of a partial anterior circulation stroke perilesional on the left hemisphere. The cathode will be positioned contralateral.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Global, Stroke, Transcranial Direct Current Stimulation, Speech Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
verum-tDCS
Arm Type
Experimental
Arm Description
verum-tDCS+ speech therapy
Arm Title
sham-tDCS
Arm Type
Sham Comparator
Arm Description
sham-tDCS + speech therapy
Intervention Type
Procedure
Intervention Name(s)
tDCS + speech therapy
Intervention Description
Patients either receive 20min of tDCS with 2mA + speech therapy every work for 6 weeks. The anodal electrode will be placed either on the homologous speech area (TACS) in the right hemisphere or on the speech area perilesional in the left hemisphere (PACS). The cathodal electrode will be placed contralateral. Patients in group B will follow the same protocol, except for the stimulation intensity (2 mA versus 0 mA) the speech therapist will apply the tdcs according to the protocol. The tdcs machine is out of sight of the patient, so that she/he does not see, whether the machine is switched on or not. In case of sham stimulation the device will be switched on very slowly for the first 20 s and will than be set back to 0mA within the following 10 s. So that the patient will feel also the characteristic tingling under the electrodes.
Primary Outcome Measure Information:
Title
Goodglass-Kaplan communication scale (GKS, 0-5)
Description
the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5.
Time Frame
10-15 min
Title
Aphasia Check-list (ACL, 0-148)
Description
a german tool to assess language (analogous to the Aachener Aphasie Test). it measures a) colour-figure test, b) word generation and c) single speech domains
Time Frame
30-45 min
Secondary Outcome Measure Information:
Title
Aphasic depression rating scale (ADRS, 0-32)
Description
rates the depression in patients with aphasia
Time Frame
5 min
Title
Alterskonzentrationstest (AKT, 0-35)
Description
assesses the concentration and vigilance of elderly people with stroke
Time Frame
5 min
Title
Barthel-Index (BI,0-100)
Description
evaluates the activities of daily living in patients suffering from stroke
Time Frame
5min
Title
Rivermead Motor Assessment - Arm (RMA, 0-15)
Description
assesses the motor control of the upper extremity in patients with stroke
Time Frame
5-10 min
Other Pre-specified Outcome Measures:
Title
Electroencephalography (EEG)
Description
to record spontaneous brain activity and to exclude increased cortical excitability
Time Frame
30min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first time stroke (ischemic or hemorrhagic), either with a total or partial anterior circulation stroke according to the Bamford classification stroke interval 10-45 days moderate or severe aphasia, i.e. Goodglass-Kaplan-Communication-Scale (GKS, 0,1 or 2) native speaker - german age 18-90 Exclusion Criteria: other neurological diseases affecting the CNS known history of epileptic fits, except for an immediate fit signs in the EEG of increased cortical excitability patients with hemicraniectomy fluent aphasia, i.e. GKS 3,4 or 5 speech apraxia reduced sensibility of the scalp previously radiated scalp metallic parts or implants in the brain participation in other interventional studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Hesse, Prof.Dr.
Phone
+49-30-300240
Ext
9312
Email
s.hesse@medicalpark.de
First Name & Middle Initial & Last Name or Official Title & Degree
Cordula Werner, Dr
Phone
+49-30-300240
Ext
9271
Email
cwerner@reha-hesse.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Hesse, Prof. Dr.
Organizational Affiliation
Medical Park Berlin, Charité - University Medicine Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Park Berlin Humboldtmuehle
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Hesse, Prof.
Phone
+49303002409310
Email
s.hesse@medicalpark.de
First Name & Middle Initial & Last Name & Degree
Cordula Werner, Dr.
Phone
+49303002409271
Email
c.werner@medicalpark.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
21825004
Citation
Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.
Results Reference
result
PubMed Identifier
24166562
Citation
Polanowska KE, Lesniak M, Seniow JB, Czlonkowska A. No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. Neurol Neurochir Pol. 2013 Sep-Oct;47(5):414-22. doi: 10.5114/ninp.2013.38221.
Results Reference
result

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tDCS and Speech Therapy to Improve Aphasia

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