- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02426983
Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination
A Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Auditory Sensory Memory Processing
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Danielle Impey, Ph.D. (cand.)
- Phone Number: 6757 613-722-6521
- Email: danielle.impey@theroyal.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Z 7K4
- University of Ottawa Institute of Mental Health Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, medication free
- Non-smoker
- Right-handed
Exclusion Criteria:
- 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
- Body mass index >38kg/m¬2
- Use of illicit drugs
- Abnormal hearing
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Direct Current Stimulation active
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.
|
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. |
Sham Comparator: Direct Current Stimulation sham
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.
|
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. |
Active Comparator: NMDA antagonist active
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.
|
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.
Other Names:
|
Placebo Comparator: NMDA antagonist placebo
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Adverse Events Scores as measure of treatment side effects
Time Frame: 1 year
|
Adverse Events and self-reported symptoms after treatment
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danielle Impey, Ph.D. (cand.), University of Ottawa Institute of Mental Health Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Respiratory System Agents
- Antitussive Agents
- Dextromethorphan
Other Study ID Numbers
- 2013008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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