Residual AphasiaStimRAphNCT01845129
Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
A study testing atDCS in people with Residual Aphasia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Residual Aphasia
- What is being tested?
- atDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Apr 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- right handedness
- German native speaker
- cerebrovascular stroke in left hemisphere (>6 months)
- mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
- residual anomia in naming test (>75 correct responses)
Who cannot join
- other current or previous neurological or psychiatric diseases
- alcohol or drug abuse
- MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite, University Medicine, Dept. of Neurology
Berlin, State of Berlin, 10117
Robert Darkow, MSc, +49 30 450 560 ext. 395, robert.darkow@charite.de
Marcus Meinzer, PhD
About this study
The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.
Read the detailed description
Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects
- Conditions
- Residual Aphasia
- Being tested
- atDCS, sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atDCSDevice
atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
sham tDCSDevice
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Experimental | atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex Receives: Device: atDCS; Device: sham tDCS |
| sham tDCS | Sham comparator | sham tDCS will be administered to the left primary hand motor cortex Receives: Device: atDCS; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response latency during picture naming task (max. 80)
Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.
Measured: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Secondary outcomes (1)
Change in neural activity measured by functional magnetic resonance imaging
Measured: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual AphasiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Meinzer, Charite University, Berlin, Germany
- Investigators
- Marcus Meinzer, PhD, Principal investigator, Charite, University Medicine, NeurologyAgnes Flöel, MD, Principal investigator, Charite, University Medicine, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845129
- Sponsor's protocol ID
- RAPH_01EO0801
- Acronym
- StimRAph
- Status last verified
- Apr 2013
- First submitted
- 30 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
- ClinicalTrials.gov ID
- NCT01845129
- Acronym / sponsor ID
- StimRAph / RAPH_01EO0801
- Conditions
- Residual Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 3 May 2013 (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 present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.
Detailed description
Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Experimental | Device: atDCS, Device: sham tDCSatDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex |
| sham tDCS | Sham comparator | Device: atDCS, Device: sham tDCSsham tDCS will be administered to the left primary hand motor cortex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- right handedness
- German native speaker
- cerebrovascular stroke in left hemisphere (>6 months)
- mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
- residual anomia in naming test (>75 correct responses)
Key exclusion criteria (3 listed)
- other current or previous neurological or psychiatric diseases
- alcohol or drug abuse
- MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
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 |
|---|---|---|
| atDCSatDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes. | Device | anodal tDCS, sham tDCS |
| sham tDCSDuring sham the current will be increeased and decreased in a ramp-like fashion (10 sec) | Device | anodal tDCS, sham tDCS |
Primary outcome
Response latency during picture naming task (max. 80)
Time frame: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.
1 secondary outcome
Change in neural activity measured by functional magnetic resonance imaging
Time frame: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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.
Marcus Meinzer, PhD principal investigator
Charite, University Medicine, Neurology
Agnes Flöel, MD principal investigator
Charite, University Medicine, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atDCS in people with Residual Aphasia, run by Charite University, Berlin, Germany 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 3 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 3 May 2013. 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 Robert Darkow, MSc (+49 30 450 560 ext. 395, robert.darkow@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response latency during picture naming task (max. 80) (time frame: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week). 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 3 May 2013.