ConcussionNCT01112761
Cortical Plasticity Assessment in Athletes With a History of Concussion
A study testing Transcranial direct current stimulation in people with Concussion, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability. Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)
- Age between 18 and 30 yr.
- Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)
- Concussion that occurred > 6 months
- All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma
- Participants are cleared for full sport participation based upon neurological and neuropsychological (NS) assessments Classified as symptomatic based on Post-concussion Symptom List
Who cannot join
- Previous significant neurological history
- Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.
- Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months
- History of seizures, depression or PTSD
- Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.
- Contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants
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- history of seizures
- unexplained loss of consciousness
- metal in the head
- frequent or severe headaches or neck pain
- implanted brain medical devices.
- Contraindications to tDCS:
- metal in the head
- implanted brain medical devices
- For the control group (subjects with no concussion) we will select subjects according to the previously stated list of exclusions as well as the following criteria: Subjects who are athletes (similar to the concussed group) with the same age range and also similar level of education; however these subjects will have no prior history of concussion or neurological insult as self reported. They should also have no contraindications to TMS or tDCS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts
About this study
The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability.
Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.
This study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.
Read the detailed description
This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).
- Conditions
- Concussion
- Being tested
- Transcranial direct current stimulation
- Keywords
- Athletes, Multiple Concussions, Transcranial Stimulation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized. Receives: Device: Transcranial direct current stimulation |
| Athletes with history of concussion | Experimental | Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability and cortical plasticity assessment
TMS and tDCS
Measured: Baseline, 1st, 2nd and 3rd week
Secondary outcomes (1)
Cognitive functioning in athletes with concussion compared to athletes without concussion
Will use the Immediate Postconcussion Assessment and Cognitive Test (IMPACT): a neuropsychological test battery that measures aspects of cognitive functioning including attention, memory, reaction time and information processing speed.
Measured: Baseline, 1st, 2nd and 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Lack of resources to run the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112761
- Sponsor's protocol ID
- 2010P000191
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2010
- Last updated
- 24 Apr 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Plasticity Assessment in Athletes With a History of Concussion
- ClinicalTrials.gov ID
- NCT01112761
- Acronym / sponsor ID
- 2010P000191
- Conditions
- Concussion
- Keywords
- Athletes, Multiple Concussions, Transcranial Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources to run the trial
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Apr 2010 (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 research is to determine whether athletes with concussion have changes in cortical excitability.
Single and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.
This study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.
Detailed description
This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: Transcranial direct current stimulationEach subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized. |
| Athletes with history of concussion | Experimental | Device: Transcranial direct current stimulationEach subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)
- Age between 18 and 30 yr.
- Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)
- Concussion that occurred > 6 months
- All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma
Key exclusion criteria (15 listed)
- Previous significant neurological history
- Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.
- Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months
- History of seizures, depression or PTSD
- Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.
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 |
|---|---|---|
| Transcranial direct current stimulationEach type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects. | Device | Athletes with history of concussion, Healthy Subjects |
Primary outcome
Cortical excitability and cortical plasticity assessment
Time frame: Baseline, 1st, 2nd and 3rd week
TMS and tDCS
1 secondary outcome
Cognitive functioning in athletes with concussion compared to athletes without concussion
Time frame: Baseline, 1st, 2nd and 3rd week
Results and safety
The study was stopped early (reason given: Lack of resources to run the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Felipe Fregni, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Concussion, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Apr 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 United States. 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?
The study was stopped early (reason given: Lack of resources to run the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability and cortical plasticity assessment (time frame: Baseline, 1st, 2nd and 3rd 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 24 Apr 2020.