What is the mechanism of action of this treatment?

Common treatments for executive function deficits often involve cognitive rehabilitation techniques that aim to enhance neural plasticity and improve cognitive processes. Music therapy, including adaptive music programs like Pi Electronics' AM, works by engaging multiple brain regions simultaneously, promoting neural connectivity and cognitive flexibility. Neurofeedback, another related treatment, helps patients self-regulate brain activity, leading to improved attention and executive control. These mechanisms are crucial for executive function patients as they directly target and enhance the brain's ability to manage complex tasks, improve decision-making, and regulate behavior, ultimately leading to better psychosocial and cognitive outcomes.

What side effects are associated with this type of intervention?

Common treatments for enhancing executive function, such as adaptive music therapy and other neuromodulation techniques, generally have minimal side effects. Adaptive music therapy, like the Pi Electronics' Adaptive Music Program, is non-invasive and typically well-tolerated, with rare reports of mild discomfort or fatigue. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), may cause mild side effects like headaches, tingling sensations, or lightheadedness, but these are usually temporary and resolve shortly after treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments solely for enhancing executive function. However, various cognitive and psychosocial interventions, including non-pharmacological methods like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), have been explored for cognitive enhancement. These methods, similar to the adaptive music technology in the Pi Electronics' Adaptive Music Program (AM), aim to improve cognitive and psychosocial outcomes. While these technologies are not FDA-approved specifically for executive function, they represent a growing field of non-invasive cognitive enhancement therapies.

What other types of research exist?

Promising novel alternatives to Pi Electronics' Adaptive Music Program (AM) for enhancing psychosocial and cognitive outcomes in executive function patients include: 1) Brain-Computer Interfaces (BCIs) with adaptive learning algorithms, which have shown improved performance in stroke rehabilitation and auditory attention tasks. 2) Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in reducing functional disability and improving cognitive functions. 3) Task-specific brain-machine interface training, which has shown significant improvements in motor function and user satisfaction in clinical settings.

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Adaptive Music Therapy for Well-being in Older Adults (AMT Trial)

N/A

Recruiting

Led By Kathryn Bolton, BA. hons

Research Sponsored by Toronto Metropolitan University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

With largely normal or corrected to normal hearing

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of music therapy on healthy older adults aged 65+. One is regular music therapy, and the other uses technology to adjust the music to improve mood. The goal is to see if these therapies can enhance mental and emotional well-being.

Who is the study for?

This trial is for healthy older adults with good or corrected hearing, no mental health diagnoses, and normal cognitive function (scoring 24+ on the Mini-Mental State Exam). Participants must have access to a computer and internet.

What is being tested?

The study tests if Pi Electronics' adaptive music intervention improves psychosocial and cognitive functions in older adults compared to traditional music therapy. It's a three-arm randomized controlled trial including pretests, posttests, and follow-ups over four weeks.

What are the potential side effects?

Since this trial involves music interventions, there are no direct physical side effects expected. However, participants may experience varying emotional responses due to the nature of therapeutic music.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My hearing is mostly normal or corrected to be normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Activities of Daily Living: Psychosocial functions of healthy older adults.

Psychosocial Functioning

Emotional processing: Cognitive functions of healthy older adults.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive Music Intervention (AM)Experimental Treatment1 Intervention

The intervention will be an adaptive music program, in which participants will listen to music provided by the research team that has been enhanced with frequencies that elicit positive moods using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks.

Group II: Traditional Music Intervention (TM)Active Control1 Intervention

The intervention will be traditional music therapy, in which participants will listen to music provided by the research team that has not been enhanced with frequencies using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks.

Group III: Control GroupActive Control1 Intervention

The control intervention will be an audiobook provided by the research team that participants will listen to using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for executive function deficits often involve cognitive rehabilitation techniques that aim to enhance neural plasticity and improve cognitive processes. Music therapy, including adaptive music programs like Pi Electronics' AM, works by engaging multiple brain regions simultaneously, promoting neural connectivity and cognitive flexibility. Neurofeedback, another related treatment, helps patients self-regulate brain activity, leading to improved attention and executive control. These mechanisms are crucial for executive function patients as they directly target and enhance the brain's ability to manage complex tasks, improve decision-making, and regulate behavior, ultimately leading to better psychosocial and cognitive outcomes.

Effects of music production on cortical plasticity within cognitive rehabilitation of patients with mild traumatic brain injury.