Post-concussion and Transcranial Direct Current Stimulation

NCT03481153 | Unknown

• 1 other identifier: UBColumbia
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Concussion, Mild

Outcome Measures

Primary Outcomes (1)

• 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?

  10 minutes

Secondary Outcomes (1)

• Symptom checklist from the Sports Assessment Concussion Assessment Tool - 5th Edition

  10 minutes

Study Arms (2)

Sham tDCS

PLACEBO COMPARATOR

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

ACTIVE COMPARATOR

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)

Interventions

Transcranial direct current stimulation (tDCS) 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

Sham tDCS; tDCS

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Naznin Virji-Babul, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naznin Virji-Babul, PhD

CONTACT

778-668-3362; naznin.virji-babul@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CA (1)