SchizophreniaPhase 1/2NCT02426983
Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination
A Phase 1/2 study testing Direct Current Stimulation and Dextromethorphan in people with Schizophrenia, run by University of Ottawa at 1 site in Canada.
Trial summary
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a very weak constant current to temporarily excite the brain area of interest via small electrodes placed on the scalp. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Direct Current Stimulation and Dextromethorphan
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 1/2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, medication free
- Non-smoker
- Right-handed
Who cannot join
- Any current or past Axis I or Axis II disorder including a current or recent history of alcohol/substance abuse
- A clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment
- Any neurological diagnosis (including epilepsy)
- Recent head trauma (<6 months)
- Metallic implants or any electrical device (e.g., pacemaker) in the body
- Major learning disability
Show all 9Show fewer
- Body mass index >38kg/m¬2
- Use of illicit drugs
- Abnormal hearing
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
About this study
Official title: A Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Auditory Sensory Memory Processing
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a very weak constant current to temporarily excite the brain area of interest via small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate mental processes (cognition) and motor function (movement) in healthy controls and to treat neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has been found to improve motor processes and cognitive performance, including attention and memory functions. This study will attempt to examine the effects of tDCS on a specific aspect of short term memory to sounds measured from electrical activity (EEG) from the top of the scalp. This study will also assess the effect of a drug, dextromethorphan (DMO), commonly found in cough syrup, which is thought to regulate tDCS treatment through brain receptors. The study involves four laboratory test sessions. EEG assessments will be done in two sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity locally), one session with DMO treatment and one with placebo treatment, and two sessions involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo treatments. These findings will contribute to our understanding of the brain chemistry involved in tDCS treatment and its effects on cognitive abilities.
- Conditions
- Schizophrenia
- Being tested
- Direct Current Stimulation, Dextromethorphan
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Current StimulationDevice
Comparison between active Direct Current Stimulation (2 mA, 20 minutes) and Sham stimulation (the device is set up, but only turned on for 30 seconds).
Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp overlying the left auditory cortex (anodal electrode) and on the contralateral forehead above the orbit (reference/cathode). Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton). In active tDCS sessions, the DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. In active tDCS, stimulation will be maintained for a total of 20 minutes. This will occur in two separate sessions, occurring within weeks. For 'sham' stimulation, the device will only be turned on for 30 seconds. This will occur in two separate sessions, occurring within weeks.
DextromethorphanDrug
Also called Life Brand Clear Cough Syrup DM
Comparison between Dextromethorphan and a no-sugar placebo. Dextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc, Brockville, ON), which has high dose of DMO (15 mg/5 ml) with no other major additives. Each subject will receive a dose of 50 ml DM with no-sugar cranberry juice (100 ml) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks. Each subject will receive a dose of a placebo (150 ml of no-sugar cranberry juice) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks.
| Study group | Role | What they receive |
|---|---|---|
| Direct Current Stimulation active | Active comparator | Electrodes will be placed on the scalp overlying the left auditory cortex (anodal electrode) and on the contralateral forehead above the orbit (reference/cathode). Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton). In active tDCS sessions, the DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. In active tDCS, stimulation will be maintained for a total of 20 minutes. This will occur in two separate sessions, occurring within weeks. Receives: Device: Direct Current Stimulation |
| Direct Current Stimulation sham | Sham comparator | In sham sessions, the device will have the same placement and intensity, but will only be turned on for 30 seconds. The DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. This will occur in two separate sessions, occurring within weeks. Receives: Device: Direct Current Stimulation |
| NMDA antagonist active | Active comparator | Dextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc, Brockville, ON). Each subject will receive a dose of 50 ml DM with no-sugar cranberry juice (100 ml) to drink. This same dose will be delivered in two separate sessions, occurring within weeks. Receives: Drug: Dextromethorphan |
| NMDA antagonist placebo | Placebo comparator | Each subject will receive a dose of a placebo (150 ml of no-sugar cranberry juice) to drink. This same dose will be delivered in two separate sessions, occurring within weeks. Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMN ERP amplitudes as a measure of sensory processing changes
Acute effects of DMO (vs. placebo) and tDCS (vs. sham) on MMN-indexed auditory sensory memory processing
Measured: 1 year
Adverse Events Scores as measure of treatment side effects
Adverse Events and self-reported symptoms after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Verner Knott, University of Ottawa
- Investigators
- Danielle Impey, Ph.D. (cand.), Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426983
- Sponsor's protocol ID
- 2013008
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Auditory Sensory Memory Processing
- ClinicalTrials.gov ID
- NCT02426983
- Acronym / sponsor ID
- 2013008
- Conditions
- Schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 27 Apr 2015 (estimated)
- 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.
Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a very weak constant current to temporarily excite the brain area of interest via small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate mental processes (cognition) and motor function (movement) in healthy controls and to treat neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has been found to improve motor processes and cognitive performance, including attention and memory functions. This study will attempt to examine the effects of tDCS on a specific aspect of short term memory to sounds measured from electrical activity (EEG) from the top of the scalp. This study will also assess the effect of a drug, dextromethorphan (DMO), commonly found in cough syrup, which is thought to regulate tDCS treatment through brain receptors. The study involves four laboratory test sessions. EEG assessments will be done in two sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity locally), one session with DMO treatment and one with placebo treatment, and two sessions involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo treatments. These findings will contribute to our understanding of the brain chemistry involved in tDCS treatment and its effects on cognitive abilities.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct Current Stimulation active | Active comparator | Device: Direct Current StimulationElectrodes will be placed on the scalp overlying the left auditory cortex (anodal electrode) and on the contralateral forehead above the orbit (reference/cathode). Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton). In active tDCS sessions, the DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. In active tDCS, stimulation will be maintained for a total of 20 minutes. This will occur in two separate sessions, occurring within weeks. |
| Direct Current Stimulation sham | Sham comparator | Device: Direct Current StimulationIn sham sessions, the device will have the same placement and intensity, but will only be turned on for 30 seconds. The DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. This will occur in two separate sessions, occurring within weeks. |
| NMDA antagonist active | Active comparator | Drug: DextromethorphanDextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc, Brockville, ON). Each subject will receive a dose of 50 ml DM with no-sugar cranberry juice (100 ml) to drink. This same dose will be delivered in two separate sessions, occurring within weeks. |
| NMDA antagonist placebo | Placebo comparator | Drug: DextromethorphanEach subject will receive a dose of a placebo (150 ml of no-sugar cranberry juice) to drink. This same dose will be delivered in two separate sessions, occurring within weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, medication free
- Non-smoker
- Right-handed
Key exclusion criteria (9 listed)
- Any current or past Axis I or Axis II disorder including a current or recent history of alcohol/substance abuse
- A clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment
- Any neurological diagnosis (including epilepsy)
- Recent head trauma (<6 months)
- Metallic implants or any electrical device (e.g., pacemaker) in the body
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 |
|---|---|---|
| Direct Current StimulationComparison between active Direct Current Stimulation (2 mA, 20 minutes) and Sham stimulation (the device is set up, but only turned on for 30 seconds). Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp overlying the left auditory cortex (anodal electrode) and on the contralateral forehead above the orbit (reference/cathode). Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton). In active tDCS sessions, the DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. In active tDCS, stimulation will be maintained for a total of 20 minutes. This will occur in two separate sessions, occurring within weeks. For 'sham' stimulation, the device will only be turned on for 30 seconds. This will occur in two separate sessions, occurring within weeks. | Device | Direct Current Stimulation active, Direct Current Stimulation sham |
| DextromethorphanAlso: Life Brand Clear Cough Syrup DMComparison between Dextromethorphan and a no-sugar placebo. Dextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc, Brockville, ON), which has high dose of DMO (15 mg/5 ml) with no other major additives. Each subject will receive a dose of 50 ml DM with no-sugar cranberry juice (100 ml) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks. Each subject will receive a dose of a placebo (150 ml of no-sugar cranberry juice) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks. | Drug | NMDA antagonist active, NMDA antagonist placebo |
Primary outcome
MMN ERP amplitudes as a measure of sensory processing changes
Time frame: 1 year
Acute effects of DMO (vs. placebo) and tDCS (vs. sham) on MMN-indexed auditory sensory memory processing
Adverse Events Scores as measure of treatment side effects
Time frame: 1 year
Adverse Events and self-reported symptoms after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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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.
Danielle Impey, Ph.D. (cand.) principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Direct Current Stimulation and Dextromethorphan in people with Schizophrenia, run by University of Ottawa 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 3 inclusion and 9 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 27 Apr 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Verner Knott, Ph.D. (613-722-6521 ext. 6843, verner.knott@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMN ERP amplitudes as a measure of sensory processing changes (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Apr 2015.