NCT06987747

Brief Summary

This research study looks at the feasibility of using a new treatment, noninvasively activating the brain through repetitive transcranial magnetic stimulation (rTMS) to treat pain symptoms of complex regional pain syndrome (CRPS). This study will help us determine if this technique is feasible (able to recruit participants and if the research activities are feasible and can be used to treat CRPS patients with pain in a larger study. The investigators will also examine how TMS can be personalized to individuals using an individual's brain activity measured using EEG. The investigators will also study whether the effects of TMS are stronger if the TMS is delivered during a specific timing of the EEG activity.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

April 23, 2025

Last Update Submit

May 22, 2025

Conditions

Complex Regional Pain Syndrome (CRPS)

Keywords

repetitive transcranial magnetic stimulationpersonalized repetitive transcranial magnetic stimulationComplex Regional Pain SyndromeCRPSElectroencephalogramEEG guided TMS

Outcome Measures

Primary Outcomes (1)

  • Accuracy of BCI

    Offline analysis of the EEG data recorded during intervention will be used to determine the true positive (TPR), false positive (FPR), true negative (TNR), and false negative rates (FNR) of the model. This aim will be achieved if 70% or more of the participants' trained BCI achieve a TPR \> 65% and an FPR \< 10%.

    Periprocedural

Secondary Outcomes (1)

  • Pain Ratings

    Immediately before intervention - immediately after intervention

Other Outcomes (1)

  • EEG assessment of Corticomuscular coherence (CMC)

    Periprocedural

Study Arms (1)

BCI training and testing group

EXPERIMENTAL

This group will contain all participants. All participants will receive the same rTMS brain stimulation, a series of 90 triplet pulses at 100 Hz.

Device: Repetitive transcranial magnetic stimulation

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 first dorsal interossei (FDI) muscle of the left motor cortex will be targeted using neuronavigation software. A series of 90 triplet pulses will be delivered at 100 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right FDI muscle. The delivery of rTMS requires \~ 15 minutes in total.

Also known as: rTMS
BCI training and testing group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of CRPS Type 1 affecting the upper or lower limb using the revised Budapest criteria
  • History of CRPS of at least 3 months since the start of symptoms or diagnosis

You may not qualify if:

  • CRPS diagnosis greater than 3 years to avoid patients with chronic CRPS who may not respond to interventions
  • Contraindications to transcranial magnetic stimulation (TMS)
  • Known psychological diagnosis affecting comprehension
  • Prior experience with TMS
  • Inability to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

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

Study Officials

  • Aimee J Nelson, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandeep K Atwal, BSc Science

CONTACT

6476330118atwala9@mcmaster.ca

Stevie Foglia, PhD

CONTACT

9053920144foglias@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Local Principal Investigator

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 23, 2025

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations

CA(1)