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Trial record 15 of 2475 for:    NMDA

Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination

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ClinicalTrials.gov Identifier: NCT02426983
Recruitment Status : Unknown
Verified April 2015 by Dr. Verner Knott, University of Ottawa.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2015
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Verner Knott, University of Ottawa

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Direct Current Stimulation Drug: Dextromethorphan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Auditory Sensory Memory Processing
Study Start Date : April 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Memory

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.
Device: Direct Current Stimulation

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.
Device: Direct Current Stimulation

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.
Drug: Dextromethorphan
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 Name: Life Brand Clear Cough Syrup DM

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.
Drug: Dextromethorphan
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 Name: Life Brand Clear Cough Syrup DM




Primary Outcome Measures :
  1. 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

  2. Adverse Events Scores as measure of treatment side effects [ Time Frame: 1 year ]
    Adverse Events and self-reported symptoms after treatment



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426983


Contacts
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Contact: Verner Knott, Ph.D. 613-722-6521 ext 6843 verner.knott@theroyal.ca
Contact: Danielle Impey, Ph.D. (cand.) 613-722-6521 ext 6757 danielle.impey@theroyal.ca

Locations
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Canada, Ontario
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z 7K4
Sponsors and Collaborators
University of Ottawa
Investigators
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Principal Investigator: Danielle Impey, Ph.D. (cand.) University of Ottawa Institute of Mental Health Research

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Responsible Party: Dr. Verner Knott, Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory, University of Ottawa
ClinicalTrials.gov Identifier: NCT02426983     History of Changes
Other Study ID Numbers: 2013008
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs