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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
Sponsor:
Information provided by (Responsible Party):
Fiza Singh, University of California, San Diego

Brief Summary:
Mild cognitive impairment (MCI) has been identified as an early phase of Alzheimer's disease (AD), a neurodegenerative disorder expected to affect 13.9 million Americans by 2060. AD causes a progressive cognitive decline, including problems related to learning and memory, that adversely affects life quality. Treatment intervention at the MCI stage of the disease could potentially slow down the rate at which people may convert from MCI to AD. Increasing evidence suggests that abnormal activity in frontal regions of the brain is associated with cognitive deficits observed in AD. Furthermore, previous research has shown that neurofeedback (NFB) training targeting these regions can improve memory, making it a potential treatment for AD. NFB is a technique where an individual learns to change his/her brain function in a particular direction, once that function has been made accessible through a visual or auditory metaphor. We are proposing a novel, computer-based brain-training program to enhance frontal gamma oscillatory activity in individuals with MCI. Results from this study will build the scientific foundation necessary for larger clinical trials dedicated to improving treatment options and outcomes for patients with MCI.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Neurofeedback Other: Placebo Not Applicable

Detailed Description:
This is a randomized, double-blind, clinical trial to test the efficacy of gamma-neurofeedback (G-NFB) compared to a placebo (P-NFB) in individuals with MCI. 112 consented participants will be randomized to receive G-NFB (n=56) or placebo-NFB (n=56) during 30-45 minute sessions twice per week for 12 weeks (24 total sessions). Memory and other cognitive domains will be measured using paper and pencil and computerized tests every 4 weeks during the study and at 4 weeks post completion of study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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.
Behavioral: Neurofeedback
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.
Other: Placebo
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet criteria for mild cognitive impairment (MCI).
  2. Living independently.
  3. Literate in English.
  4. Competent to participate in the informed consent process and provide voluntary informed consent.

Exclusion Criteria:

  1. Frontal temporal dementia
  2. Active alcohol or substance use disorder within the past year.
  3. Brain cancer
  4. Stroke within the last 2 years
  5. Anti-epileptic medication
  6. Prior head injury involving loss of consciousness
  7. Seizure disorder
  8. 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).
  9. The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.

Information from the National Library of Medicine

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


Contacts
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Contact: Veronica Gandara, B.S. 858-267-2257 vgandara@health.ucsd.edu
Contact: Fiza Singh, M.D. fsingh@health.ucsd.edu

Locations
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United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Fiza Singh, MD    858-922-4365    fsingh@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Publications:
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Responsible Party: Fiza Singh, Associate Professor of Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04566900    
Other Study ID Numbers: 192022
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fiza Singh, University of California, San Diego:
neurofeedback
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders