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.

Study Overview

• Status: Terminated
• Conditions: Concussion
• Intervention / Treatment: Device: Transcranial direct current stimulation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical excitability and cortical plasticity assessment	TMS and tDCS	Baseline, 1st, 2nd and 3rd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1st, 2nd and 3rd week

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Felipe Fregni, PhD, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Athletes; Transcranial Stimulation; Multiple Concussions
• Other Study ID Numbers: 2010P000191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No