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Augmented Reality Training + rTMS for Chronic Neck Pain

N/A

Recruiting

Led By Aimee Nelson, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

A diagnosis of chronic neck pain

Be older than 18 years old

Must not have

A known history of moderate to severe chronic pain in other parts of the body

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 week before intervention, immediately before intervention, immediately following intervention, 2 weeks after intervention

Summary

This trial aims to test if augmented reality sensorimotor training +/or repetitive transcranial magnetic stimulation (rTMS) can reduce chronic neck pain. A feasibility study of 40 patients will be done to test procedures.

Who is the study for?

This trial is for individuals with chronic neck pain who can understand the study and participate fully. It's not suitable for those with severe chronic pain elsewhere, contraindications to magnetic stimulation, or psychological conditions affecting comprehension.

What is being tested?

The study tests if augmented reality sensorimotor training can relieve chronic neck pain and whether adding repetitive transcranial magnetic stimulation (rTMS) before the training improves outcomes. Participants will also complete questionnaires and functional assessments.

What are the potential side effects?

Possible side effects include discomfort from wearing augmented reality equipment and mild headaches or scalp sensations from rTMS. The sham procedure may have no side effects but won't provide treatment benefits.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with chronic neck pain.

Exclusion Criteria

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

Select...

I have chronic pain that is moderate to severe in parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following the 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

Ability to recruit 20 patients in each group over a 6-month period

Compliance of treatment sessions for the two groups

Secondary study objectives

Active cervical range of movement (CROM)

Augmented Reality Time to Target

Motor evoked potential recruitment curve

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group B (Active)Experimental Treatment2 Interventions

Participants in group B will take part in 2-4 weeks of treatment with 3-5 sessions per week. Each session will involve both real repetitive transcranial magnetic stimulation (rTMS) and augmented reality. Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. rTMS will take approximately 11.5 minutes. Immediately following rTMS, participants will perform augmented reality sensorimotor training. Participants will perform 20 minutes of sensorimotor training.

Group II: Group A (Sham)Placebo Group2 Interventions

Participants in group A will take part in 2-4 weeks of treatment with 3-5 sessions per week. Each session will involve both sham repetitive transcranial magnetic stimulation (rTMS) and augmented reality sensorimotor training. Sham repetitive transcranial magnetic stimulation (rTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. Participants will hear and experience the clicking but will not be provided with any stimulation. Sham rTMS will take approximately 11.5 minutes. Immediately following sham rTMS, participants will perform augmented reality sensorimotor training. Participants will perform 20 minutes of sensorimotor training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive transcranial magnetic stimulation

2008

Completed Phase 3

~1000

0 / 2Eligibility criteria met