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

A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04002167

Enrollment

Registered

2019-06-28

Start date

2019-08-16

Completion date

2022-09-14

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, Working memory, functional near infrared spectroscopy (fNIRS), magnetic resonance imaging (MRI), Neurofeedback, Cognitive training, Neuromonitoring

Brief summary

The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.

Interventions

BEHAVIORALNeurofeedback

The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.

BEHAVIORALCognitive training

The Cognitive training group will receive computerized working memory training with performance feedback.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 11 Years

Healthy volunteers

Inclusion criteria

include: * Age from 7 to 11 years * Diagnosis and/or current symptoms of ADHD * Full-scale Intelligence quotient (IQ) ≥80 * Behavior Rating Inventory of Executive Functions (BRIEF), Working Memory Scale t-score \> 65 * Allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression.

Exclusion criteria

* Presence of severe neurological or psychiatric disease other than those allowed under inclusion * Sensory deficits that would preclude participation in assessments or imaging * History of significant head trauma with loss of consciousness * Contraindications to MRI (e.g. metal implants or claustrophobia) * Enrollment in other intervention studies

Design outcomes

Primary

Measure	Time frame	Description
Change in Working Memory Performance	baseline and 6 weeks	Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.
Change in Target Frontal-parietal Activity	baseline and 6 weeks	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.

Secondary

Measure	Time frame	Description
Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score	baseline and 6 weeks	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
Change in Conners 3rd Edition ADHD Index Score	baseline and 6 weeks	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.
Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score	baseline and 6 weeks	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.
Change in Conners 3rd Edition Inattention T-score	baseline and 6 weeks	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.
Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score	baseline and 6 weeks	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.

Other

Measure	Time frame	Description
Change in California Verbal Learning Test - Children's Version (CVLT-C) Score	baseline and 6 weeks	CVLT-C test measures performance in learning and recalling verbal materials
Change in Continuous Performance Test (CPT) Accuracy	baseline and 6 weeks	CPT is standard test for measuring vigilance, sustained attention and inhibitory control.
Change in Parent Stress Index 4th Edition (PSI-IV)	baseline and 6 weeks	PSI-IV evaluates the magnitude of stress in the parent-child system

Countries

United States

Participant flow

Participants by arm

Arm	Count
Neurofeedback (Phase I) The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.	21
Waitlist (Phase I) Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.	15
Total	36

Baseline characteristics

Characteristic	Neurofeedback (Phase I)	Waitlist (Phase I)	Total
Age, Categorical <=18 years	21 Participants	15 Participants	36 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	9 Participants	3 Participants	12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	8 Participants	10 Participants	18 Participants
Region of Enrollment United States	21 Participants	15 Participants	36 Participants
Sex: Female, Male Female	9 Participants	7 Participants	16 Participants
Sex: Female, Male Male	12 Participants	8 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 33	0 / 32
other Total, other adverse events	1 / 33	0 / 32
serious Total, serious adverse events	0 / 33	0 / 32

Outcome results

Primary

Change in Target Frontal-parietal Activity

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.