Post-concussion and Transcranial Direct Current Stimulation

• ClinicalTrials.gov Identifier: NCT03481153
• Recruitment Status: Unknown
• First Posted: March 29, 2018
• Last Update Posted: March 29, 2018
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Naznin Virji-Babul, University of British Columbia

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:

1. To determine the tolerability of a 20-minute session of tDCS in symptomatic youth athletes;
2. 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.

Condition or disease	Intervention/treatment	Phase
Concussion, Mild	Device: Transcranial direct current stimulation (tDCS)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post-concussion and Transcranial Direct Current Stimulation
• Estimated Study Start Date: April 2018
• Estimated Primary Completion Date: April 2019
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Sham tDCS; 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.	Device: Transcranial direct current stimulation (tDCS); 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
Active Comparator: tDCS; 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.	Device: Transcranial direct current stimulation (tDCS); 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

Outcome Measures

Primary Outcome Measures :

1. Comfort Rating Questionnaire (CRQ) [ Time Frame: 10 minutes ]
   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 :

1. Symptom checklist from the Sports Assessment Concussion Assessment Tool - 5th Edition [ Time Frame: 10 minutes ]
   Participants are asked to indicate the symptom severity of 22 symptoms on the checklist. The scores range from 0 (none) to 6 (severe)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Naznin Virji-Babul, PhD; 778-668-3362; naznin.virji-babul@ubc.ca

Locations

Canada, British Columbia

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, Canada, V6T 1Z3

Contact: Fidel Vila-Rodriguez, MD, PhD (604)-827-1361 fidel.vilarodriguez@ubc.ca

Contact: Angela Muller, PhD 604 827 4966 angela.muller@ubc.ca

Principal Investigator: Naznin Virji-Babul, PhD

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Naznin Virji-Babul, PhD; University of British Columbia

More Information

• Responsible Party: Naznin Virji-Babul, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03481153
• Other Study ID Numbers: UBColumbia
• First Posted: March 29, 2018
• Last Update Posted: March 29, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Brain Concussion; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating