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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Compliance of treatment sessions for the two groups

Secondary outcome measures

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

~920

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,276 Total Patients Enrolled

St. Joseph's Healthcare HamiltonOTHER

196 Previous Clinical Trials

25,504 Total Patients Enrolled

Aimee Nelson, PhDPrincipal InvestigatorMcMaster University

2 Previous Clinical Trials

44 Total Patients Enrolled

Media Library

Augmented Reality Sensorimotor Training Clinical Trial Eligibility Overview. Trial Name: NCT05880511 — N/A

Chronic Neck Pain Research Study Groups: Group B (Active), Group A (Sham)

Chronic Neck Pain Clinical Trial 2023: Augmented Reality Sensorimotor Training Highlights & Side Effects. Trial Name: NCT05880511 — N/A

Augmented Reality Sensorimotor Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880511 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must an individual meet to join this trial?

"People with chronic neck pain between the ages of 40 and 80 are eligible to take part in this study, which is currently seeking out forty participants."

Answered by AI

Are there any vacant spots for participants in this clinical experiment?

"The clinical trial is no longer seeking candidates, as reported on clinicialtrials.gov. Initially posted on July 1st 2023 and last updated May 19th of the same year, this project has been superseded by 81 other trials searching for participants at present."

Answered by AI

Does this research endeavor admit participants aged sixty or older?

"To be eligible for this trial, potential participants must have a chronological age between 40 and 80. Additionally, there are two trials available for those under 18 years old as well as 44 options to choose from if you are over 65."

Answered by AI

What effects are researchers seeking to achieve with this experiment?

"The primary evaluation of this clinical trial, which will follow the administration of the intervention, is assessing treatment adherence in both groups. Secondary objectives involve measuring pain intensity using a Visual Analog Scale (VAS), Pressure Pain Threshold (PPT) and the Patient Perceived Global Index of Change (PGIC). VAS entails participants indicating their level on a 10 cm line ranging from no pain to worst imaginable; PPT measures deep tissue sensitivity by applying pressure until it turns into an unpleasant sensation; PGIC involves subjects rating their progress as "very much improved,""much improved," etc., according to 1-7 Likert scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Augmented Reality Sensorimotor Training to Treat Chronic Neck

Aimee Nelson 2024. "Augmented Reality Sensorimotor Training to Treat Chronic Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880511.

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