Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Enhancing Gamma Band Response in Mild Cognitive Impairment to Improve Working Memory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566900
• Other study ID #: 192022
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: September 2023
• Source: University of California, San Diego
• Contact: Joshua Phillips, B.S.
• Phone: 858-267-2257
• Email: j7phillips[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 31, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of California at San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (5)

Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Working Memory accuracy	Change in the computerized test, N-back will be used to measure working memory.	From baseline to 12 weeks of treatment
Secondary	Durability of Change in Working Memory accuracy	Change in the computerized test, N-back will be used to measure working memory.	From baseline to 4weeks post end of study
Secondary	Change in Gamma Band Response	Change in Gamma oscillations will be measured while the subject performs the n-back task.	From baseline to 12 weeks of treatment
Secondary	Durability of Gamma Band Response	Change in Gamma oscillations will be measured while the subject performs the n-back task.	From baseline to 4weeks post end of study