Post-concussion and Transcranial Direct Current Stimulation

NCT ID: NCT03481153

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2020-04-30

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.

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.

Conditions

Concussion, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Naznin Virji-Babul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naznin Virji-Babul, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Naznin Virji-Babul, PhD

Role: CONTACT

naznin.virji-babul@ubc.ca

778-668-3362

Facility Contacts

Fidel Vila-Rodriguez, MD, PhD

Role: primary

fidel.vilarodriguez@ubc.ca

(604)-827-1361

Angela Muller, PhD

Role: backup

angela.muller@ubc.ca

604 827 4966

Other Identifiers

UBColumbia

Identifier Type: -

Identifier Source: org_study_id