Clinical trial NCT03338673: Brain Stimulation and Cognitive Training
Official title: Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Schizo Affective Disorder
Schizophrenia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Participant Retention in Combination Treatment
timeFrame: 4 weeks
measure: Participant-rated Acceptability of Combination Therapy
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cynthia Burton, PhD
role: PRINCIPAL_INVESTIGATOR
References: