Neurofeedback to Improve Working Memory in Mild Cognitive Impairment
Enhancing Gamma Band Response in Mild Cognitive Impairment to Improve Working Memory
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Fiza Singh, M.D.
- Email: fsingh@health.ucsd.edu
Study Contact Backup
- Name: Autumn Harris, B.S.
- Phone Number: 858-267-2257
- Email: avharris@health.ucsd.edu
Study Locations
-
-
California
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La Jolla, California, United States, 92093
- University of California at San Diego
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meet criteria for mild cognitive impairment (MCI).
- Living independently.
- Literate in English.
- Competent to participate in the informed consent process and provide voluntary informed consent.
Exclusion Criteria:
- Frontal temporal dementia
- Active alcohol or substance use disorder within the past year.
- Brain cancer
- Stroke within the last 2 years
- Anti-epileptic medication
- Prior head injury involving loss of consciousness
- Seizure disorder
- Use of medications likely to affect cognitive function (cf. donepezil, memantine). We will not exclude for other medications but will examine their effects and include medications as covariates as appropriate (e.g., presence v. absence; anticholinergic load).
- The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Working Memory accuracy
Time Frame: From baseline to 12 weeks of treatment
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Change in the computerized test, N-back will be used to measure working memory.
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From baseline to 12 weeks of treatment
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From baseline to 4weeks post end of study
|
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Change in Gamma Band Response
Time Frame: From baseline to 12 weeks of treatment
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Change in Gamma oscillations will be measured while the subject performs the n-back task.
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From baseline to 12 weeks of treatment
|
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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.
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From baseline to 4weeks post end of study
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Dohnel K, Sommer M, Ibach B, Rothmayr C, Meinhardt J, Hajak G. Neural correlates of emotional working memory in patients with mild cognitive impairment. Neuropsychologia. 2008 Jan 15;46(1):37-48. doi: 10.1016/j.neuropsychologia.2007.08.012. Epub 2007 Aug 23.
- Leuchter AF, Newton TF, Cook IA, Walter DO, Rosenberg-Thompson S, Lachenbruch PA. Changes in brain functional connectivity in Alzheimer-type and multi-infarct dementia. Brain. 1992 Oct;115 ( Pt 5):1543-61. doi: 10.1093/brain/115.5.1543.
- Uhlhaas PJ, Singer W. Neural synchrony in brain disorders: relevance for cognitive dysfunctions and pathophysiology. Neuron. 2006 Oct 5;52(1):155-68. doi: 10.1016/j.neuron.2006.09.020.
- Stam CJ, van Cappellen van Walsum AM, Pijnenburg YA, Berendse HW, de Munck JC, Scheltens P, van Dijk BW. Generalized synchronization of MEG recordings in Alzheimer's Disease: evidence for involvement of the gamma band. J Clin Neurophysiol. 2002 Dec;19(6):562-74. doi: 10.1097/00004691-200212000-00010.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 192022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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