NCT01112761

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

April 20, 2010

Last Update Submit

April 23, 2020

Conditions

Concussion

Keywords

AthletesMultiple ConcussionsTranscranial Stimulation

Outcome Measures

Primary Outcomes (1)

  • Cortical excitability and cortical plasticity assessment

    TMS and tDCS

    Baseline, 1st, 2nd and 3rd week

Secondary Outcomes (1)

  • Cognitive functioning in athletes with concussion compared to athletes without concussion

    Baseline, 1st, 2nd and 3rd week

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

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

Athletes with history of concussion

EXPERIMENTAL

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

Interventions

Transcranial direct current stimulationDEVICE

Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.

Athletes with history of concussionHealthy Subjects

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Felipe Fregni, PhD

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)