NCT05197959

Brief Summary

This study will investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) and a sensorimotor training task to treat symptoms of pain in patients with complex regional pain syndrome (CRPS). rTMS is a non-invasive technique that involves delivering magnetic pulses in rapid succession over the area of the brain that controls movement. The sensorimotor training task involves non-invasive nerve stimulation used to cue a participant to complete motor actions. The purpose of this study is to determine whether recruitment is feasible in this patient population and patients maintain adherence to the intervention. In addition, the investigators want to determine whether rTMS combined with sensorimotor training is an effective intervention to alleviate symptoms of pain in patients with CRPS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

December 7, 2021

Last Update Submit

October 17, 2023

Conditions

Complex Regional Pain Syndrome

Keywords

repetitive transcranial magnetic stimulationsensorimotor trainingcomplex regional pain syndrome

Outcome Measures

Primary Outcomes (2)

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

    Ability to recruit 6 patients in each group over a 6-month period at the chronic pain clinic at St Joseph's Healthcare Hamilton.

    Immediately following the 4 week intervention.

  • Compliance of treatment sessions as proposed

    Percentage of participants that completed all treatment sessions. We expect \>90% patients in each group to adhere to sessions.

    Immediately following the 4 week intervention.

Secondary Outcomes (16)

  • Complex Regional Pain Syndrome Severity Scale

    1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention

  • PROMIS-29 v2.0 Profile

    1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention

  • Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Pain Score

    1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention

  • The Rainbow Pain Scale

    1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention

  • Douleur Neuropathique 4 (DN4 Scale)

    1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention

  • +11 more secondary outcomes

Study Arms (3)

Group A-Control

NO INTERVENTION

Participants in this arm will not experience any intervention during a 4 week period of time. Participants will experience their standard medical care.

Group B-rTMS and sensorimotor training

EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. Immediately following rTMS, participants will perform sensorimotor training. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.

Device: Repetitive transcranial magnetic stimulationOther: Sensorimotor training

Group C-Sensorimotor training

EXPERIMENTAL

Participants will perform sensorimotor training intervention. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.

Other: Sensorimotor training

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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-rTMS and sensorimotor training
Sensorimotor trainingOTHER

Sensorimotor training is a non-invasive, non-painful procedure using nerve stimulation to cue motor action. Nerve stimulation is applied the second through the fifth digit and the median nerve at the wrist. This stimulation is used to cue a motor action. The number of stimulations will indicate the amount of movements. For example, two pulses of stimulations to the index finger would require two flexion and extension actions with the index finger. Once the stimulation occurs, the participant will flex and extend the corresponding area where the nerve stimulation was felt. This will take \~ 30 minutes to complete.

Group B-rTMS and sensorimotor trainingGroup C-Sensorimotor training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of CRPS type 1 affecting one of their hands

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton King Campus

Hamilton, Ontario, L8G5E4, Canada

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Aimee Nelson, PhD

CONTACT

9055259140nelsonaj@mcmaster.ca

Stevie Foglia, MSc

CONTACT

9053920144foglias@mcmaster.ca

Study Design

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

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 20, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

CA(1)