Brain Stimulation and Cognitive Training

Schizophrenia Clinical Trial

Official title:

Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338673
• Other study ID #: HUM00119204
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: September 27, 2019

Study information

• Verified date: August 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

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:
• BrainHQ
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Retention in Combination Treatment	Number of participants completing every session of the combined phase of treatment	4 weeks
Primary	Participant-rated Acceptability of Combination Therapy	Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)	8 weeks