Cortical Plasticity Assessment in Athletes With a History of Concussion

This study has been terminated.
(Lack of resources to run the trial)
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01112761
First received: April 20, 2010
Last updated: April 22, 2013
Last verified: April 2013

April 20, 2010
April 22, 2013
April 2010
December 2013   (final data collection date for primary outcome measure)
Cortical excitability and cortical plasticity assessment [ Time Frame: Baseline, 1st, 2nd and 3rd week ] [ Designated as safety issue: No ]
TMS and tDCS
Same as current
Complete list of historical versions of study NCT01112761 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Cortical Plasticity Assessment in Athletes With a History of Concussion
Cortical Plasticity Assessment in Athletes With a History of Concussion

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.

This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Concussion
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.
  • Experimental: Healthy Subjects
    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.
    Intervention: Device: Transcranial direct current stimulation
  • Experimental: Athletes with history of concussion
    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.
    Intervention: Device: Transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01112761
2010P000191
No
Felipe Fregni, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: Felipe Fregni, PhD Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP