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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):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Bipolar Disorder Schizo Affective Disorder Schizophrenia Device: tDCS Other: BrainHQ

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Official Title: Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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: 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
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


Outcome Measures

Primary Outcome Measures :
  1. Participant retention in combination treatment [ Time Frame: 7 weeks ]
    Percentage of participants completing the combined phase of treatment

  2. Participant-rated acceptability of combination therapy [ Time Frame: 7 weeks ]
    Self-reported satisfaction as indicated on a numerical rating scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT03338673


Contacts
Contact: Cynthia Burton, PhD 734-763-9259 czburton@umich.edu
Contact: Brianna Preiser, BS 734-764-1234 preisebj@umich.edu

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Cynthia Burton, PhD University of Michigan
More Information

Responsible Party: Cynthia Burton, Research Fellow, Department of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03338673     History of Changes
Other Study ID Numbers: HUM00119204
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders