Concussed AthletesNCT01593956
Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes
A study testing tDCS in people with Concussed Athletes and Healthy Controls, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussed Athletes, Healthy Controls
- What is being tested?
- tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Jul 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- history of at least 2 sports concussion
- age 18 - 50 years
Who cannot join
- structural deficit on cerebral MRI
- Epilepsy
- neurological disorder
- intake of CNS-active drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Department of neurology
Berlin, 10117
Jonathan List, MD, +40 30 450560223, Jonathan.List@charite.de
Agnes Flöel, Prof., +40 30 450660284, agnes.floeel@charite.de
About this study
Official title: Influence of Anodal Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes and Healthy Volunteers
Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what have been found in concussed athletes by paired pulse protocols in TMS.
GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased tDCS.
Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in concussed athlethes.
- Conditions
- Concussed Athletes, Healthy Controls
- Being tested
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Concussed athletes | Other | Not described Receives: Behavioral: tDCS |
| Healthy controls | Other | Not described Receives: Behavioral: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of cortical plasticity after anodal tDCS in concussed athletes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Concussed AthletesStudies 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
- Treatment
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan List, Charite University, Berlin, Germany
- Investigators
- Jonathan List, MD, Principal investigator, Charité - Department of NeurologyAgnes Flöel, Prof., Principal investigator, Charité - Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593956
- Sponsor's protocol ID
- EA1/021/12
- Status last verified
- May 2013
- First submitted
- 7 May 2012
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
De Beaumont L, Tremblay S, Poirier J, Lassonde M, Theoret H. Altered bidirectional plasticity and reduced implicit motor learning in concussed athletes. Cereb Cortex. 2012 Jan;22(1):112-21. doi: 10.1093/cercor/bhr096. Epub 2011 May 13.
PubMed 21572090Stagg CJ, Bachtiar V, Johansen-Berg H. The role of GABA in human motor learning. Curr Biol. 2011 Mar 22;21(6):480-4. doi: 10.1016/j.cub.2011.01.069. Epub 2011 Mar 3.
PubMed 21376596Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
PubMed 19386916
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anodal Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01593956
- Acronym / sponsor ID
- EA1/021/12
- Conditions
- Concussed Athletes, Healthy Controls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (estimated)
- First posted
- 8 May 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.
Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what have been found in concussed athletes by paired pulse protocols in TMS.
GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased tDCS.
Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in concussed athlethes.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed athletes | Other | Behavioral: tDCS |
| Healthy controls | Other | Behavioral: tDCS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- history of at least 2 sports concussion
- age 18 - 50 years
Key exclusion criteria (4 listed)
- structural deficit on cerebral MRI
- Epilepsy
- neurological disorder
- intake of CNS-active drugs
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 | Behavioural | Concussed athletes, Healthy controls |
Primary outcome
Improvement of cortical plasticity after anodal tDCS in concussed athletes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Background: PubMed 21572090De Beaumont L, Tremblay S, Poirier J, Lassonde M, Theoret H. Altered bidirectional plasticity and reduced implicit motor learning in concussed athletes. Cereb Cortex. 2012 Jan;22(1):112-21. doi: 10.1093/cercor/bhr096. Epub 2011 May 13.
- Background: PubMed 21376596Stagg CJ, Bachtiar V, Johansen-Berg H. The role of GABA in human motor learning. Curr Biol. 2011 Mar 22;21(6):480-4. doi: 10.1016/j.cub.2011.01.069. Epub 2011 Mar 3.
- Background: PubMed 19386916Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
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.
Jonathan List, MD principal investigator
Charité - Department of Neurology
Agnes Flöel, Prof. principal investigator
Charité - Department of 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 tDCS in people with Concussed Athletes and Healthy Controls, 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 2 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 23 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of cortical plasticity after anodal tDCS in concussed athletes. 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 NCT01593956, which also lists 3 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 23 May 2013.