Aphasia, GlobalMP-LOGANCT02395874
tDCS and Speech Therapy to Improve Aphasia
A study testing tDCS + speech therapy in people with Aphasia, Global and Stroke, run by Medical Park AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia, Global, Stroke, Transcranial Direct Current Stimulation
- What is being tested?
- tDCS + speech therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- reduced sensibility of the scalp
- previously radiated scalp
- metallic parts or implants in the brain
- participation in other interventional studies
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Park Berlin Humboldtmuehle
Berlin, State of Berlin, 13507
Stefan Hesse, Prof., +49303002409310, s.hesse@medicalpark.de
Cordula Werner, Dr., +49303002409271, c.werner@medicalpark.de
About this study
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
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.
Read the 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.
- Being tested
- tDCS + speech therapy
- Medical subject headings
- Aphasia, Stroke, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS + speech therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| verum-tDCS | Experimental | verum-tDCS+ speech therapy Receives: Procedure: tDCS + speech therapy |
| sham-tDCS | Sham comparator | sham-tDCS + speech therapy Receives: Procedure: tDCS + speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-15 min
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
Measured: 30-45 min
Secondary outcomes (4)
Aphasic depression rating scale (ADRS, 0-32)
rates the depression in patients with aphasia
Measured: 5 min
Alterskonzentrationstest (AKT, 0-35)
assesses the concentration and vigilance of elderly people with stroke
Measured: 5 min
Barthel-Index (BI,0-100)
evaluates the activities of daily living in patients suffering from stroke
Measured: 5min
Rivermead Motor Assessment - Arm (RMA, 0-15)
assesses the motor control of the upper extremity in patients with stroke
Measured: 5-10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aphasia, GlobalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Park AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cordula Werner, Medical Park AG
- Investigators
- Stefan Hesse, Prof. Dr., Principal investigator, Medical Park Berlin, Charité - University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395874
- Sponsor's protocol ID
- MP-LOGA
- Acronym
- MP-LOGA
- Status last verified
- Sep 2016
- First submitted
- 11 Mar 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21825004Polanowska 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.
PubMed 24166562
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02395874
- Acronym / sponsor ID
- MP-LOGA / MP-LOGA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Medical Park AGIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum-tDCS | Experimental | Procedure: tDCS + speech therapyverum-tDCS+ speech therapy |
| sham-tDCS | Sham comparator | Procedure: tDCS + speech therapysham-tDCS + speech therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS + speech therapyPatients 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. | Procedure or surgery | sham-tDCS, verum-tDCS |
Primary outcome
Goodglass-Kaplan communication scale (GKS, 0-5)
Time frame: 10-15 min
the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5.
Aphasia Check-list (ACL, 0-148)
Time frame: 30-45 min
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
4 secondary outcomes
Aphasic depression rating scale (ADRS, 0-32)
Time frame: 5 min
Alterskonzentrationstest (AKT, 0-35)
Time frame: 5 min
Barthel-Index (BI,0-100)
Time frame: 5min
Rivermead Motor Assessment - Arm (RMA, 0-15)
Time frame: 5-10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Results publication: PubMed 21825004Hesse 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 publication: PubMed 24166562Polanowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Hesse, Prof. Dr. principal investigator
Medical Park Berlin, Charité - University Medicine Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS + speech therapy in people with Aphasia, Global and Stroke, run by Medical Park AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Hesse, Prof.Dr. (+49-30-300240 ext. 9312, s.hesse@medicalpark.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goodglass-Kaplan communication scale (GKS, 0-5) (time frame: 10-15 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395874, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.