AphasiaNCT03882502
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
A study of Aphasia and TBI (Traumatic Brain Injury), run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, TBI (Traumatic Brain Injury), tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 31 Dec 2020
- 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
- aphasia assessed by Aachener Aphasie Test (AAT) > 6 month after moderate TBI
- Age: 18 - 80 years
- right handedness
Who cannot join
- dementia or other neurological diseases
- History of severe alcoholism or use of drugs
- Severe psychiatric disorders such as depression, psychosis (if not in remission)
- Severe untreated medical problems such as cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University medicine Greifswald
Greifswald, 17475
Agnes Floeel, Prof, +49 3834 86 6815, agnes.floeel@uni-greifswald.de
Katharina Wuesten, PhD, +49 3834 86 6754, Katharina.wuesten@uni-greifswald.de
About this study
Official title: The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI
- Conditions
- Aphasia, TBI (Traumatic Brain Injury), tDCS
- Being tested
- anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation
- Medical subject headings
- Aphasia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulationOther
anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| stimulation group | Experimental | Not described Receives: Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation |
| sham stimulation | Sham comparator | Not described Receives: Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naming ability assessed by
Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Feb 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- P.A.N.-Zentrum, Unfallkrankenhaus Berlin, Kliniken Beelitz GmbH
- Responsible party
- Sponsor
- Investigators
- Agnes Floeel, Prof, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882502
- Sponsor's protocol ID
- BISCUIT Trial 2019
- Status last verified
- Feb 2020
- First submitted
- 18 Mar 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
- ClinicalTrials.gov ID
- NCT03882502
- Acronym / sponsor ID
- BISCUIT Trial 2019
- Conditions
- Aphasia, TBI (Traumatic Brain Injury), tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- P.A.N.-Zentrum, Unfallkrankenhaus Berlin, Kliniken Beelitz GmbH
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Mar 2019 (actual)
- 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 aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation group | Experimental | Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation |
| sham stimulation | Sham comparator | Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aphasia assessed by Aachener Aphasie Test (AAT) > 6 month after moderate TBI
- Age: 18 - 80 years
- right handedness
Key exclusion criteria (4 listed)
- dementia or other neurological diseases
- History of severe alcoholism or use of drugs
- Severe psychiatric disorders such as depression, psychosis (if not in remission)
- Severe untreated medical problems such as cancer
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 |
|---|---|---|
| anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulationanodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention. | Other | sham stimulation, stimulation group |
Primary outcome
Naming ability assessed by
Time frame: 2 weeks
Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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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.
Agnes Floeel, Prof principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Aphasia and TBI (Traumatic Brain Injury), run by University Medicine Greifswald 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 3 inclusion and 4 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 7 Feb 2020. 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 Agnes Floeel, Prof (+49 3834 86 6815, agnes.floeel@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naming ability assessed by (time frame: 2 weeks). 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 7 Feb 2020.