Cortical Plasticity Assessment in Athletes With a History of Concussion
| Tracking Information | |||||
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| First Received Date ICMJE | April 20, 2010 | ||||
| Last Updated Date | April 22, 2013 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cortical excitability and cortical plasticity assessment [ Time Frame: Baseline, 1st, 2nd and 3rd week ] [ Designated as safety issue: No ] TMS and tDCS |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01112761 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cognitive functioning in athletes with concussion compared to athletes without concussion [ Time Frame: Baseline, 1st, 2nd and 3rd week ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cortical Plasticity Assessment in Athletes With a History of Concussion | ||||
| Official Title ICMJE | Cortical Plasticity Assessment in Athletes With a History of Concussion | ||||
| Brief 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. 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. |
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| Detailed Description | This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Concussion | ||||
| Intervention ICMJE | Device: Transcranial direct current stimulation
Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 1 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. |
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| Gender | Both | ||||
| Ages | 18 Years to 30 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01112761 | ||||
| Other Study ID Numbers ICMJE | 2010P000191 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Felipe Fregni, Spaulding Rehabilitation Hospital | ||||
| Study Sponsor ICMJE | Spaulding Rehabilitation Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Spaulding Rehabilitation Hospital | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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