Brain Stimulation and Cognitive Training - Efficacy

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111548
• Other study ID #: HUM00119204b
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: May 12, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with serious mental illness often experience 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 helpful in improving a specific type of memory skill in people who have mental health conditions.

The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.

Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 12, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia

• Willingness to participate in study procedures

Exclusion Criteria:

• History of neurological illness or injury (e.g., stroke)

• History of loss of consciousness

• Diagnosed intellectual disability

• Current substance use disorder

• Current mania or moderate depression or severe psychosis

• Current serious suicidal ideation/behavior

• Pregnant or trying to become pregnant, or currently lactating

Related Conditions & MeSH terms

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

Intervention

Device:
• tDCS (Active)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.

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

Device:
• tDCS (Inactive)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.

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	Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score	MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).	Baseline to post-treatment (up to 4 weeks)
Primary	Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score	MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).	Baseline to post-treatment (up to 4 weeks)
Secondary	Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A	The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).	Baseline to post-treatment (up to 4 weeks)
Secondary	Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B	Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).	Baseline to post-treatment (up to 4 weeks)