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
  Purpose

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.


Condition Intervention Phase
Concussion
Device: Transcranial direct current stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cortical Plasticity Assessment in Athletes With a History of Concussion

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Cortical excitability and cortical plasticity assessment [ Time Frame: Baseline, 1st, 2nd and 3rd week ] [ Designated as safety issue: No ]
    TMS and tDCS


Secondary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: April 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112761

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01112761     History of Changes
Other Study ID Numbers: 2010P000191
Study First Received: April 20, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spaulding Rehabilitation Hospital:
Athletes
Multiple Concussions
Transcranial Stimulation

ClinicalTrials.gov processed this record on August 19, 2014