Concussion, MildNCT03481153
Post-concussion and Transcranial Direct Current Stimulation
A study testing Transcranial direct current stimulation (tDCS) in people with Concussion, Mild, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3
Fidel Vila-Rodriguez, MD, PhD, (604)-827-1361, fidel.vilarodriguez@ubc.ca
Angela Muller, PhD, 604 827 4966, angela.muller@ubc.ca
About this study
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.
Read the 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
- Being tested
- Transcranial direct current stimulation (tDCS)
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 10 minutes
Secondary outcomes (1)
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naznin Virji-Babul, University of British Columbia
- Investigators
- Naznin Virji-Babul, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481153
- Sponsor's protocol ID
- UBColumbia
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-concussion and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03481153
- Acronym / sponsor ID
- UBColumbia
- Conditions
- Concussion, Mild
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Placebo comparator | Device: Transcranial direct current stimulation (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. |
| tDCS | Active comparator | Device: Transcranial direct current stimulation (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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Sham tDCS, tDCS |
Primary outcome
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?
1 secondary outcome
Symptom checklist from the Sports Assessment Concussion Assessment Tool - 5th Edition
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naznin Virji-Babul, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Concussion, Mild, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naznin Virji-Babul, PhD (778-668-3362, naznin.virji-babul@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Rating Questionnaire (CRQ) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.