Augmented Reality Sensorimotor Training to Treat Chronic Neck

NCT05880511 | Recruiting

• 1 other identifier: 16310
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this research is to investigate whether 2-4 weeks of augmented reality sensorimotor training induces positive changes so as to effect pain relief in patients with chronic neck pain. In addition, this study aims to determine if repetitive transcranial magnetic stimulation (rTMS) delivered prior to augmented reality sensorimotor training enhances the benefits from the sensorimotor training. This study will also use a battery of questionnaires, functional assessments and electroencephalography markers to identify changes following the sensorimotor training that may be associated with benefits in pain symptoms. Before we embark on a larger study, we plan to investigate the feasibility of our study procedures in a feasibility study involving 40 patients.

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

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

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

  Immediately following the intervention.

• Compliance of treatment sessions for the two groups

  Compliance of sessions is defined as a minimum of attending 3 sessions per week for 2 weeks.

  Immediately following the intervention.

Secondary Outcomes (10)

• PROMIS-29 v2.0 Profile

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

• Visual analog scale

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

• Pressure pain threshold (PPT)

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

• Patient Perceived Global Index of Change (PGIC)

  Immediately following intervention, 2 weeks after intervention

• The neck disability index

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

Study Arms (2)

Group A (Sham)

SHAM COMPARATOR

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.

Device: Augmented Reality Sensorimotor Training; Device: Sham Repetitive transcranial magnetic stimulation

Group B (Active)

EXPERIMENTAL

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.

Device: Repetitive transcranial magnetic stimulation; Device: Augmented Reality Sensorimotor Training

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. 2000 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right APB muscle. The delivery of rTMS requires \~ 11.5 minutes in total.

Also known as: rTMS, Repetitive TMS

Group B (Active)

Augmented Reality Sensorimotor Training DEVICE

Sensorimotor training is a non-invasive, non-painful procedure using augmented reality to present virtual objects which cue motor action. Augmented reality allows us to project virtual objects overlaid on the user's actual environment. The sensorimotor training task involves making movements with the head and neck such that a target crosshair presented in the centre of the glasses is moved to a virtual target that is presented in the user's environment. Participants will perform 20 minutes of sensorimotor training. The goal of augmented reality sensorimotor training is to promote goal directed actions using the head and neck.

Group A (Sham); Group B (Active)

Sham Repetitive transcranial magnetic stimulation DEVICE

Sham repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, non-painful procedure. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. During the sham, participants will hear and experience the clicking from the device but will not be provided with any stimulation. The delivery of sham rTMS requires \~ 11.5 minutes in total.

Group A (Sham)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of chronic neck pain

You may not qualify if:

• A known history of moderate to severe chronic pain in other parts of the body
• Contraindications to transcranial magnetic stimulation,
• Known psychological diagnosis affecting comprehension
• Inability to participate in the study

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton King Campus

Hamilton, Ontario, L8G5E4, Canada

NOT YET RECRUITING

McMaster Unviersity

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Aimee Nelson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Nelson, PhD

CONTACT

9055259140; nelsonaj@mcmaster.ca

Stevie Foglia, MSc

CONTACT

9053920144; foglias@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: March 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (2)