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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

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination
Official Title  ICMJE A Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Auditory Sensory Memory Processing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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.

  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Direct Current Stimulation
  • 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.
    Intervention: Device: Direct Current Stimulation
  • 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.
    Intervention: Drug: Dextromethorphan
  • 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.
    Intervention: Drug: Dextromethorphan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 21, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2016
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426983
Other Study ID Numbers  ICMJE 2013008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Verner Knott, University of Ottawa
Study Sponsor  ICMJE University of Ottawa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Danielle Impey, Ph.D. (cand.) University of Ottawa Institute of Mental Health Research
PRS Account University of Ottawa
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP