Trial Outcomes & Findings for A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT04002167)

NCT ID: NCT04002167

Last Updated: 2023-12-13

Results Overview

Change in activity in the target frontal-parietal network measured by functional near infrared spectroscopy (fNIRS) during an N-back working memory task. A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: baseline and 6 weeks
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Neurofeedback (Phase I) The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.	Cognitive Training (Phase II) The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
Overall Study STARTED	33	32	0
Overall Study COMPLETED	21	15	0
Overall Study NOT COMPLETED	12	17	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	Neurofeedback (Phase I) n=21 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=15 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=93 Participants	15 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	8 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) More than one race	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=93 Participants	15 Participants n=4 Participants	36 Participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data are included in the analysis

Change in activity in the target frontal-parietal network measured by functional near infrared spectroscopy (fNIRS) during an N-back working memory task. A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.

Outcome measures

Measure	Neurofeedback (Phase I) n=20 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=14 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Target Frontal-parietal Activity	2.31 beta coefficient Standard Deviation 1.73	-4.74 beta coefficient Standard Deviation 2.50

PRIMARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data are included in the analysis.

Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.

Outcome measures

Measure	Neurofeedback (Phase I) n=20 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=14 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Working Memory Performance	2.12 percent change in accuracy Standard Deviation 15.70	-0.53 percent change in accuracy Standard Deviation 12.09

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data are included in the analysis.

BRIEF assesses everyday behavior associated with specific domains of the executive functions. BRIEF working memory T-score ranges from <30 to >100 with higher scores indicating larger impairment in working memory. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits in working memory.

Outcome measures

Measure	Neurofeedback (Phase I) n=21 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=15 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score	-8.4 t-score Standard Deviation 6.1	-0.85 t-score Standard Deviation 7.94

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data were included in the analysis.

WRAML-2 assesses clinical issues in learning and memory functions. WRAML-2 Working Memory Index score ranges from 50 to 150 with higher scores indicating better working memory performance

Outcome measures

Measure	Neurofeedback (Phase I) n=18 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=14 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score	6.6 score on a scale Standard Deviation 16.36	9.38 score on a scale Standard Deviation 11.21

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data were included in the analysis.

Conners 3 will be used to measure changes in clinical ADHD symptoms. Conners 3 ADHD index score ranges from 0 to 100 with higher scores indicating elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis.

Outcome measures

Measure	Neurofeedback (Phase I) n=21 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=15 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Conners 3rd Edition ADHD Index Score	-6.21 score on a scale Standard Deviation 10.61	-1 score on a scale Standard Deviation 3.49

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with usable data were included in the analysis.

Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from <30 to >100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention.

Outcome measures

Measure	Neurofeedback (Phase I) n=21 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=15 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Conners 3rd Edition Inattention T-score	-4.8 t-score Standard Deviation 11.3	0.41 t-score Standard Deviation 6.38

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: participants with usable data were included in the analysis.

NEPSY-II consists of a set of subtests measuring cognitive functions required for success in school. The subtests include auditory attention & response, inhibition, word-list interference, and comprehension of instructions. The composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities.

Outcome measures

Measure	Neurofeedback (Phase I) n=21 Participants The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=15 Participants Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score	0.72 units on a scale Standard Deviation 2.56	1.05 units on a scale Standard Deviation 2.79

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 weeks

CPT is standard test for measuring vigilance, sustained attention and inhibitory control.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 weeks

CVLT-C test measures performance in learning and recalling verbal materials

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 weeks

PSI-IV evaluates the magnitude of stress in the parent-child system

Outcome measures

Outcome data not reported

Adverse Events

Neurofeedback (Phase I)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Waitlist (Phase I)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neurofeedback (Phase I) n=33 participants at risk The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	Waitlist (Phase I) n=32 participants at risk Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Eye disorders feeling of heat in an eye	3.0% 1/33 • Up to 2 months	0.00% 0/32 • Up to 2 months

Additional Information

Hadi Hosseini

Stanford University

Phone: 6507235798

Email: hosseiny@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place