Recruiting

Augmented Reality

Sponsor:

McMaster University

Code:

NCT05880511

Conditions

Chronic Neck Pain

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Repetitive transcranial magnetic stimulation

Augmented Reality Sensorimotor Training

Sham Repetitive transcranial magnetic stimulation

Study Details

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

Study ID

NCT05880511

Start date

Mar 1, 2024

Status verified date

Mar, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A diagnosis of chronic neck pain

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Group A (Sham)

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.

experimental: Group B (Active)

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.

Interventions

Repetitive transcranial magnetic stimulation

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.

Augmented Reality Sensorimotor Training

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.

Sham Repetitive transcranial magnetic stimulation

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.

Primary outcome measure

  • Ability to recruit 20 patients in each group over a 6-month period [ Time Frame: Immediately following the intervention. ]
  • Compliance of treatment sessions for the two groups [ Time Frame: Immediately following the intervention. ]

Central Contacts and Locations

Central contacts

Aimee Nelson, PhD

9055259140nelsonaj@mcmaster.ca

Stevie Foglia, MSc

9053920144foglias@mcmaster.ca

Locations

McMaster Unviersity

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Aimee J Nelson, PhD

905-525-9140nelsonaj@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-03-15.