Reducing Pain in Complex Regional Pain Syndrome Using Personalized Brain Stimulation: A Feasibility Study

ConditionComplex Regional Pain Syndrome (CRPS)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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 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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: BCI training and testing groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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%.

Time frame

Periprocedural

Secondary outcomes

Pain Ratings

Pain ratings will be measured before and after intervention in all 12 participants using the Numeric Pain Rating Scale (NRPS). Ratings will be compared before and after the intervention. The NPRS is an 11-item questionnaire that gauges participants' pain on scales of 0-10, with 0 being no pain and 10 being the worst possible pain. The NRPS has a minimum possible value of 0 and a maximum of 110.

Time frame

Immediately before intervention - immediately after intervention

Other outcomes

EEG assessment of Corticomuscular coherence (CMC)

This will include an assessment of CMC using EEG electrodes. CMC will be recorded as a single value between 0-1 with 0 representing no coherence and 1 representing complete coherence.

Time frame

Periprocedural

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Michael G. DeGroote Institute for Pain Research and Care (IPRC)

Collaborator

Source ClinicalTrials.gov

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