What side effects are associated with this type of intervention?

Non-pharmacologic treatments for Mild Cognitive Impairment (MCI), such as cognitive training and occupational therapy, generally have minimal side effects. These interventions aim to improve cognitive function and daily living skills without the adverse effects associated with medications. However, patients may experience frustration or fatigue during intensive training sessions. Pharmacologic treatments, like cholinesterase inhibitors, can cause side effects such as gastrointestinal issues, insomnia, muscle cramps, and fatigue. It is essential to monitor patients for these side effects and adjust treatment plans accordingly.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Mild Cognitive Impairment (MCI), primarily focusing on cholinesterase inhibitors like donepezil and NMDA receptor antagonists like memantine. These medications aim to improve cognitive function and slow the progression of symptoms. While the CoPILOT trial emphasizes a non-pharmacological approach involving shared control training with an occupational therapist to enhance driving skills and safety, this method is not directly related to FDA-approved pharmacological treatments. Instead, it represents an innovative, therapeutic strategy to improve functional abilities and quality of life in individuals with cognitive impairments.

What other types of research exist?

Promising alternatives to CoPILOT for MCI patients include: 1) Dynamic Useful Field of View (UFOV) Training, which has shown improvements in balance and gait speed; 2) Noninvasive neuromodulation therapy, which has demonstrated effectiveness in reducing tremor severity and improving motor control; and 3) Biomechanical loading devices, such as wearable robots and neuroprostheses, which can assist in motor function and stability.

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CoPILOT Training for Cognitive Impairment (CoPILOT Trial)

Phase 1

Waitlist Available

Led By William C Miller, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Be physically able to operate a powered wheelchair joystick

Have sustained a spinal cord injury

Must not have

Have a visual or hearing impairment which may compromise training safety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-randomization), 5 weeks (immediate post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help people with cognitive impairments learn to use powered wheelchairs more effectively. The CoPILOT system lets users control the wheelchair while allowing therapists to take over when needed for safety. This approach is expected to improve users' skills and confidence compared to other methods. The CoPILOT system has been shown to help individuals with cognitive impairments learn to operate powered wheelchairs effectively.

Who is the study for?

This trial is for individuals who can physically use a powered wheelchair joystick, have suffered a spinal cord injury, and have mild to moderate cognitive impairment. They should be new to using powered wheelchairs or previously denied one due to learning difficulties from cognitive impairments.

What is being tested?

The study tests the CoPILOT training method against standard care in teaching people with cognitive challenges how to use power wheelchairs. It involves occupational therapist-led sessions using either shared control wheelchairs or conventional training methods.

What are the potential side effects?

Since this trial focuses on training methods rather than medication, traditional side effects are not applicable. However, participants may experience frustration or fatigue during the learning process.

Eligibility Criteria

Inclusion Criteria

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

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I can use a powered wheelchair joystick.

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I have had a spinal cord injury.

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I am new to using powered wheelchairs or was previously denied one due to learning difficulties.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a visual or hearing impairment that could affect my safety during training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-randomization), 5 weeks (immediate post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-randomization), 5 weeks (immediate post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-randomization), 5 weeks (immediate post-intervention) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Power-mobility Indoor Driving Assessment (PIDA)

Secondary study objectives

Change in Health Utility Index Mark 3 (HUI3)

Change in The Wheelchair Outcome Measure (WhOM)

Change in Wheelchair Skills Test Questionnaire (WST-P-Q)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CoPILOTExperimental Treatment1 Intervention

Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (one hour, four times per week for three weeks).

Group II: Standard of CareActive Control1 Intervention

Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair, consisting of 12 hour protocols in a standard power wheelchair (one hour, four times per week for three weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CoPILOT

2016

Completed Phase 1

~40

0 / 4Eligibility 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 Mild Cognitive Impairment (MCI) include cholinesterase inhibitors, which work by increasing levels of acetylcholine in the brain to improve cognitive function, and non-pharmacologic interventions such as cognitive training and rehabilitation. The CoPILOT study's approach, involving shared control training with an occupational therapist, aligns with non-pharmacologic strategies by focusing on enhancing cognitive and functional skills through structured, supportive training. This method is particularly important for MCI patients as it aims to maintain or improve their daily living skills and independence, potentially slowing the progression of cognitive decline.