StrokeTDCS-aphasiaNCT01701713
TDCS in Acute Stroke
A study testing DKI ED2011 in people with Stroke, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- DKI ED2011
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2009to Jun 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first media stroke
- language impairment
- informed consent
- right handedness
- NIHSS < 20
Who cannot join
- previous Epilepsy oder epileptogenic events
- epilepsy typical elements in EEG
- hypersensitive skin (head)
- metal implants (head)
- pace maker or other electronic implants
- previous head/brain surgery
- medication reducing seizure threshold
- previous psychiatric events
Trial locations and contacts
2 sites in 1 country.
Gerhard J Jungehuelsing, MD contact
Isabell Wartenburger, Prof. MD contact
Germany2 sites, 1 recruiting
- Completed
Charité, Campus Benjamin Franklin, Dep. of Neurology
Berlin, State of Berlin, 12200
- Recruiting
Brandenburg Klinik Bernau
Bernau bei Berlin, Brandenburg, 16321
Michael Joebges, Prof. MD, Joebges@Brandenburgklinik.de
Michael Joebges, Prof. MD
About this study
Official title: Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.
Read the detailed description
TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.
- Conditions
- Stroke
- Being tested
- DKI ED2011, Sham-TDCS
- Keywords
- TDCS, STROKE, APHASIA, NAMING
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKI ED2011Device
Sham-TDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| TDCS - DKI ED2011 | Experimental | TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues Receives: Device: DKI ED2011 |
| Sham-TDCS | Sham comparator | Sham-TDCS session is followed by a behavioral naming therapy with different cues Receives: Device: Sham-TDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin irritation
Measured: 2 months
Secondary outcomes (1)
Improved language
improved picture naming
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Brandenburg Klinik, Bernau, Germany, University of Potsdam
- Responsible party
- Principal investigator, Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
- Investigators
- Gerhard J Jungehuelsing, MD, Principal investigator, Center for Stroke Research Berlin (CSB), CharitéMichael Joebges, Prof. MD, Principal investigator, Brandenburgklinik Bernau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701713
- Sponsor's protocol ID
- TDCS_CSB-Brandenburg
- Other IDs
- EA4/109/08
- Acronym
- TDCS-aphasia
- Status last verified
- Oct 2012
- First submitted
- 26 Sep 2012
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
- ClinicalTrials.gov ID
- NCT01701713
- Acronym / sponsor ID
- TDCS-aphasia / TDCS_CSB-Brandenburg
- Conditions
- Stroke
- Keywords
- TDCS, STROKE, APHASIA, NAMING
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Brandenburg Klinik, Bernau, Germany, University of Potsdam
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Oct 2012 (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.
The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.
Detailed description
TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDCS - DKI ED2011 | Experimental | Device: DKI ED2011TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues |
| Sham-TDCS | Sham comparator | Device: Sham-TDCSSham-TDCS session is followed by a behavioral naming therapy with different cues |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first media stroke
- language impairment
- informed consent
- right handedness
- NIHSS < 20
Key exclusion criteria (8 listed)
- previous Epilepsy oder epileptogenic events
- epilepsy typical elements in EEG
- hypersensitive skin (head)
- metal implants (head)
- pace maker or other electronic implants
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 |
|---|---|---|
| DKI ED2011 | Device | TDCS - DKI ED2011 |
| Sham-TDCS | Device | Sham-TDCS |
Primary outcome
skin irritation
Time frame: 2 months
1 secondary outcome
Improved language
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
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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.
Gerhard J Jungehuelsing, MD contact
Isabell Wartenburger, Prof. MD contact
Gerhard J Jungehuelsing, MD principal investigator
Center for Stroke Research Berlin (CSB), Charité
Michael Joebges, Prof. MD principal investigator
Brandenburgklinik Bernau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DKI ED2011 in people with Stroke, run by Charite University, Berlin, Germany at 2 sites 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 8 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Gerhard J Jungehuelsing, MD (jan.jungehuelsing@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin irritation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2012.