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Brain Stimulation and Cognitive Training

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ClinicalTrials.gov Identifier: NCT03338673
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

November 6, 2017
November 9, 2017
December 5, 2017
January 2018
January 2020   (Final data collection date for primary outcome measure)
  • Participant retention in combination treatment [ Time Frame: 7 weeks ]
    Percentage of participants completing the combined phase of treatment
  • Participant-rated acceptability of combination therapy [ Time Frame: 7 weeks ]
    Self-reported satisfaction as indicated on a numerical rating scale
Same as current
Complete list of historical versions of study NCT03338673 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Brain Stimulation and Cognitive Training
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.

People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.

This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.

Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
Masking: None (Open Label)
Primary Purpose: Other
  • Bipolar Disorder
  • Schizo Affective Disorder
  • Schizophrenia
  • Device: tDCS
    tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
    Other Name: Transcranial direct current stimulation
  • Other: BrainHQ
    BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
    Other Name: Computerized cognitive exercises
  • Experimental: Dual Therapy First
    Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone
    Interventions:
    • Device: tDCS
    • Other: BrainHQ
  • Experimental: Mono Therapy First
    Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises
    Interventions:
    • Device: tDCS
    • Other: BrainHQ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
  • Objective cognitive impairment in working memory
  • Willingness to complete computerized cognitive training and undergo brain stimulation procedures

Exclusion Criteria:

  • History of neurological illness or brain injury (e.g., stroke)
  • History of loss of consciousness
  • Diagnosed intellectual disability
  • Current substance use disorder
  • Current mania or moderate depression or severe psychosis
  • Serious suicidal ideation/behavior
  • Pregnant or trying to become pregnant, or currently lactating
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact: Cynthia Burton, PhD 734-763-9259 czburton@umich.edu
Contact: Brianna Preiser, BS 734-764-1234 preisebj@umich.edu
United States
 
 
NCT03338673
HUM00119204
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: No
Cynthia Burton, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Cynthia Burton, PhD University of Michigan
University of Michigan
December 2017

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