Neurofeedback to Improve Working Memory in Mild Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT04566900|
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Neurofeedback Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||MCI subjects will be assigned to active intervention or placebo.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Double-blind, randomized.|
|Official Title:||Enhancing Gamma Band Response in Mild Cognitive Impairment to Improve Working Memory|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||September 30, 2025|
|Estimated Study Completion Date :||March 31, 2026|
Experimental: Active Treatment
Subjects will be given a choice of videos consisting of still images set to music. Whether the video progresses and music continues to play will depend on the subject's ability to maintain frontal gamma oscillatory activity within a prespecified range. Over successive weeks, the parameters for positive feedback (music and video progression) will become incrementally more difficult.
Neurofeedback is a technique where brain functions are made accessible to the subject in the form of a metaphor. For instance, frontal brain activity may be shown as an airplane flying. Once the activity is made accessible, the subject can modulate it in a pre-specified direction. The parameters used to achieve successful feedback are made difficult over time and hence the brain is taught or conditioned to improve performance.
Sham Comparator: Placebo
Video and music progression will be random and will not depend on brain activity. Any progression will be by random chance alone.
Subjects in this arm will undergo all of the same testing as active treatment. Music and video progression will not depend on brain activity. Instead feedback will be random.
- Change in Working Memory accuracy [ Time Frame: From baseline to 12 weeks of treatment ]Change in the computerized test, N-back will be used to measure working memory.
- Durability of Change in Working Memory accuracy [ Time Frame: From baseline to 4weeks post end of study ]Change in the computerized test, N-back will be used to measure working memory.
- Change in Gamma Band Response [ Time Frame: From baseline to 12 weeks of treatment ]Change in Gamma oscillations will be measured while the subject performs the n-back task.
- Durability of Gamma Band Response [ Time Frame: From baseline to 4weeks post end of study ]Change in Gamma oscillations will be measured while the subject performs the n-back task.
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): NCT04566900
|Contact: Veronica Gandara, B.S.||firstname.lastname@example.org|
|Contact: Fiza Singh, M.D.||email@example.com|
|United States, California|
|University of California at San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Fiza Singh, MD 858-922-4365 firstname.lastname@example.org|