Cortical Plasticity Assessment in Athletes With a History of Concussion

Concussion Clinical Trial

Official title:

Cortical Plasticity Assessment in Athletes With a History of Concussion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01112761
• Other study ID #: 2010P000191
• Status: Terminated
• Phase: N/A
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussion

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical excitability and cortical plasticity assessment	TMS and tDCS	Baseline, 1st, 2nd and 3rd week
Secondary	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