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Post-concussion and Transcranial Direct Current Stimulation

Primary Purpose

Concussion, Mild

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic youth athletes (between18-25 years) who are between one to three months post concussion (participants will have had a witnessed head impact during a practice or game and be diagnosed with a concussion by team medical staff).
  2. Regular participation in organized sport (>2 practice or games per week)

Exclusion Criteria:

  1. No history of a developmental disorder.
  2. No prior moderate-to-severe traumatic brain injury.
  3. Fewer than four lifetime concussions (any cause),
  4. No diagnosis or family history of schizophrenia, major depressive disorder, bipolar disorder or other psychiatric diagnosis
  5. no previous history of seizures.

Sites / Locations

  • Djavad Mowafaghian Centre for Brain Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham tDCS

tDCS

Arm Description

Participants will be participate in a 20-minute sham tDCS session. tDCS electrodes will be placed on the left (anodal positive polarity) and right (cathodal;negative polarity) dorsolateral prefrontal cortex. Sham stimulation will be applied.

Participants will participate in a 20-minute tDCS session. tDCS electrodes will be placed on the left (anodal positive polarity) and right (cathodal;negative polarity) dorsolateral prefrontal cortex.

Outcomes

Primary Outcome Measures

Comfort Rating Questionnaire (CRQ)
The scale asks participants to rate the following during and after the stimulation on a scale from 1-10 with 1 = not all all and 10= extremely: pain, tingling, burning, fatigue, nervousness, disturbed concentration, disturbed visual perception, headache. Three additional questions (yes/no response) are also asked: 1) Was the stimulation uncomfortable, 2)Did you notice a flash during/after the stimulation and 3) Did you notice sleep disturbances after the stimulation?

Secondary Outcome Measures

Symptom checklist from the Sports Assessment Concussion Assessment Tool - 5th Edition
Participants are asked to indicate the symptom severity of 22 symptoms on the checklist. The scores range from 0 (none) to 6 (severe)

Full Information

First Posted
March 15, 2018
Last Updated
March 27, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03481153
Brief Title
Post-concussion and Transcranial Direct Current Stimulation
Official Title
Post-concussion and Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Children and youth are at a greater risk of concussions than adults, and once injured, take longer to recover. The increased incidence of sports-related concussion in youth and the potentially serious long-term negative impact on their developing brains has enormous repercussions. While most young athletes recover within several days, many continue to experience symptoms for many months post-concussion. Symptoms are wide ranging and include - most notably: headache, sleep disturbances, brain fog, irritability as well as impairments in emotion and cognitive function (i.e. attention, memory, concentration, etc.). Yet there are no evidence-based intervention studies that have successfully addressed these symptoms. Thus, there is an urgent need for improved therapeutic strategies, which promote optimal functional recovery in youth concussion. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention. Our long-term goal is to determine whether exercise combined with neurostimulation improves recovery from concussion. However, to our knowledge, the therapeutic potential of tDCS has not been studied in youth with concussion. Our objectives are as follows: To determine the tolerability of a 20-minute session of tDCS in symptomatic youth athletes; To evaluate the association between symptoms and EEG metrics at baseline and following a single session of tDCS in symptomatic athletes and compare these associations in symptomatic athletes who do not receive tDCS.
Detailed Description
Transcranial direct current stimulation is a non-invasive technique of neuromodulation that is inexpensive, easy to use and more importantly shows great promise to modify cortical excitability. Application of a weak direct current through the scalp has been shown to induce polarity specific changes in the excitability of cortical neurons23. This effect of transcranial direct current stimulation was first demonstrated in the human motor cortex. Since then it has also shown to be effective for other brain regions such as visual, somatosensory or frontal regions. The advantage of tDCS in managing concussion is that this technique can be used to focally suppress or enhance neuronal firing depending on the size and location of the applied electrodes. Thus, at different points during the trajectory of concussion, the technique can be matched to the underlying pathophysiology. For example, work by Demitras et al suggests that cathodal tDCS may be used to suppress the acute glutamatergic hyperexcitability in the acute stages of brain injury; in the subacute stage, when GABAergic activity is excessive, anodal tDCS may increase excitability to counter these aberrant GABAergic effects. In the chronic stage, brain stimulation coupled to rehabilitation may enhance behavioral recovery, learning of new skills and cortical plasticity. Thus far, one pilot study has shown that a single session of anodal tDCS over the dorsolateral prefrontal cortex was associated with improvements in attention in adults with chronic TBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
Participants will be participate in a 20-minute sham tDCS session. tDCS electrodes will be placed on the left (anodal positive polarity) and right (cathodal;negative polarity) dorsolateral prefrontal cortex. Sham stimulation will be applied.
Arm Title
tDCS
Arm Type
Active Comparator
Arm Description
Participants will participate in a 20-minute tDCS session. tDCS electrodes will be placed on the left (anodal positive polarity) and right (cathodal;negative polarity) dorsolateral prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
tDCS is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention
Primary Outcome Measure Information:
Title
Comfort Rating Questionnaire (CRQ)
Description
The scale asks participants to rate the following during and after the stimulation on a scale from 1-10 with 1 = not all all and 10= extremely: pain, tingling, burning, fatigue, nervousness, disturbed concentration, disturbed visual perception, headache. Three additional questions (yes/no response) are also asked: 1) Was the stimulation uncomfortable, 2)Did you notice a flash during/after the stimulation and 3) Did you notice sleep disturbances after the stimulation?
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Symptom checklist from the Sports Assessment Concussion Assessment Tool - 5th Edition
Description
Participants are asked to indicate the symptom severity of 22 symptoms on the checklist. The scores range from 0 (none) to 6 (severe)
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic youth athletes (between18-25 years) who are between one to three months post concussion (participants will have had a witnessed head impact during a practice or game and be diagnosed with a concussion by team medical staff). Regular participation in organized sport (>2 practice or games per week) Exclusion Criteria: No history of a developmental disorder. No prior moderate-to-severe traumatic brain injury. Fewer than four lifetime concussions (any cause), No diagnosis or family history of schizophrenia, major depressive disorder, bipolar disorder or other psychiatric diagnosis no previous history of seizures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naznin Virji-Babul, PhD
Phone
778-668-3362
Email
naznin.virji-babul@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naznin Virji-Babul, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fidel Vila-Rodriguez, MD, PhD
Phone
(604)-827-1361
Email
fidel.vilarodriguez@ubc.ca
First Name & Middle Initial & Last Name & Degree
Angela Muller, PhD
Phone
604 827 4966
Email
angela.muller@ubc.ca
First Name & Middle Initial & Last Name & Degree
Naznin Virji-Babul, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Post-concussion and Transcranial Direct Current Stimulation

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