Effects of a Novel Neurofeedback Protocol on ADHD Subcomponents (NFB@HOME)

University Hospitals (UH)

Status: Active, not recruiting

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Other: CONTROL; Other: NEUROFEEDBACK

Study type: Interventional

Funder types: Other

Identifiers

NCT04408521

SNCTP000002260 (Registry Identifier)

2017-01029

Details and patient eligibility

About

Mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (NFB), may represent a new therapeutic opportunity for patients with Attentional Deficit/Hyperactivity Disorder (ADHD), which manifests as difficulties with attention and inhibitory control. In this context, the investigators have focused on an attention-enhancing form of NFB based on the EEG alpha rhythm, known to influence sensory detection and attention. In light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-NFB, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home.

A short- (single-session) and a long-term (multi-session) experimental design will be used to collect EEG, behavioral, and clinical data pre-to-post NFB. The single-blind study will recruit 48 adult ADHD participants randomly assigned to either NEUROFEEDBACK or CONTROL groups. Each participant will undergo individual at home sessions of 45-minute video-replay of popular television (TV) series while recording their 1-channel EEG (30 sessions, 5 sessions/week, 6 weeks total). In the NEUROFEEDBACK group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. In the CONTROL group, the recording will be passive without real-time EEG neurofeedback (i.e. constant brightness and volume). Before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) EEG session including resting state and task-related EEG before and after a short NFB intervention (30 minutes). For the CONTROL group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback.

Given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-NFB (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. These results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.

Enrollment: 5 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of ADHD
• Currently stabilized (euthymic)
• General good health
• Normal or corrected-to normal visual acuity

Exclusion criteria

• Mood Disorders
• PTSD
• Borderline Personality Disorder
• Substance Use Disorder
• Structural Brain Abnormalities
• Cerebrovascular Disease
• Epilepsy
• Stroke
• Head Trauma
• Cardiovascular Disease
• Renal Failure
• Hepatic Dysfunction
• Impaired visual acuity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

NEUROFEEDBACK

Experimental group

Description:

Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. Self-regulation of alpha rhythm is reflected in the dynamically varying opacity of the video replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively.

Treatment:

Other: NEUROFEEDBACK

CONTROL

Placebo Comparator group

Description:

Participants undergo individual at home sessions of 45-minute video-replay of popular TV series while recording their 1-channel EEG using a portable system. The recording is passive without real-time EEG neurofeedback (i.e. constant brightness and volume).

Treatment:

Other: CONTROL