rTMS + Rehabilitation for Complex Regional Pain Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: State University of New York - Upstate Medical University
Disqualifiers: Seizures, Epilepsy, Pacemaker, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Subjects with complex regional pain syndrome (CRPS) Type 1 will be randomized to receive repeated transcranial magnetic stimulation (rTMS) followed by rehabilitation or sham rTMS followed by rehabilitation. Treatment will last for 4 weeks, with the first week including 4 rTMS treatments and 2 rehabilitation treatments. Subsequent weeks will include 2 rTMS treatments followed by 2 rehabilitation treatments. Outcome measures will include pain ratings, PROMIS questionnaires, global rating of change, and grip strength or 1 repetition maximum leg press.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot start any new treatments during the study.
What data supports the effectiveness of the treatment rTMS + Rehabilitation for Complex Regional Pain Syndrome?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can reduce pain in patients with complex regional pain syndrome (CRPS), with significant pain relief reported in several studies. Additionally, combining rTMS with rehabilitation therapies like physical and occupational therapy may enhance overall treatment effectiveness by addressing both pain and functional recovery.
12345Is rTMS safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) has been studied in humans for conditions like complex regional pain syndrome (CRPS) and has shown to be generally safe, with no significant adverse effects reported in the studies. It involves using magnetic fields to stimulate nerve cells in the brain, and while it can cause mild discomfort or headaches, serious side effects are rare.
12356How does the treatment rTMS differ from other treatments for complex regional pain syndrome?
rTMS (repeated transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate the brain's motor cortex, which can reduce pain perception in complex regional pain syndrome. Unlike traditional medications, rTMS directly targets brain activity and has shown to provide pain relief shortly after treatment, with effects lasting for a limited time.
12345Eligibility Criteria
This trial is for individuals with CRPS Type 1, a pain condition affecting limbs, who've had it for at least 6 months. They must have stable treatment plans and moderate pain levels. It's not suitable for those with mental disorders preventing consent, non-English speakers, seizure history, metallic brain devices, pacemakers, or pregnant women.Inclusion Criteria
I have had CRPS Type 1 in an arm or leg for at least 6 months.
I haven't started any new treatments, like medications or rehab, in the last 2 months.
No plan to initiate a new intervention during the study treatment timeframe (4 weeks)
+1 more
Exclusion Criteria
I have a history of seizures or epilepsy.
Intracranial metallic devices
Pacemaker
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either real or sham rTMS followed by rehabilitation over 4 weeks
4 weeks
10 sessions (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Surveys at 4 weeks, 3 months, 6 months, and 1 year
Participant Groups
The study tests if repeated transcranial magnetic stimulation (rTMS) combined with rehabilitation can reduce pain in CRPS Type 1 patients. Participants are randomly assigned to real rTMS or sham (fake) rTMS plus rehab over four weeks to compare the effects on pain and physical function.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: rTMS and RehabilitationExperimental Treatment2 Interventions
Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.
Group II: Sham rTMS and RehabilitationPlacebo Group2 Interventions
Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.
Repeated Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Chronic pain
- Depression
- Anxiety disorders
- Complex Regional Pain Syndrome (CRPS)
🇪🇺 Approved in European Union as rTMS for:
- Major depressive disorder
- Chronic pain
- Complex Regional Pain Syndrome (CRPS)
🇨🇦 Approved in Canada as rTMS for:
- Major depressive disorder
- Chronic pain
- Complex Regional Pain Syndrome (CRPS)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SUNY Upstate Medical Univeristy Institute of Human PerformanceSyracuse, NY
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Who Is Running the Clinical Trial?
State University of New York - Upstate Medical UniversityLead Sponsor
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)Collaborator
References
Repetitive transcranial magnetic stimulation of the motor cortex attenuates pain perception in complex regional pain syndrome type I. [2019]In complex regional pain syndrome (CRPS) many clinical symptoms suggest involvement of the central nervous system. Neuropathic pain as the leading symptom is often resistant to therapy. In the present study we investigated the analgesic efficiency of repetitive transcranial magnetic simulation (rTMS) applied to the motor cortex contralateral to the CRPS-affected side. Seven out of ten patients reported decreased pain intensities. Pain relief occurred 30 s after stimulation, whereas the maximum effect was found 15 min later. Pain re-intensified increasingly 45 min after rTMS. In contrast, sham rTMS did not alter pain perception. These findings provide evidence that in CRPS I pain perception can be modulated by repetitive motor cortex stimulation.
Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. [2022]Single-session repetitive transcranial magnetic stimulation (rTMS) of the motor cortex (M1) is effective in the treatment of chronic pain patients, but the analgesic effect of repeated sessions is still unknown. We evaluated the effects of rTMS in patients with refractory pain due to complex regional pain syndrome (CRPS) type I. Twenty-three patients presenting CRPS type I of 1 upper limb were treated with the best medical treatment (analgesics and adjuvant medications, physical therapy) plus 10 daily sessions of either real (r-) or sham (s-) 10 Hz rTMS to the motor cortex (M1). Patients were assessed daily and after 1 week and 3 months after the last session using the Visual Analogical Scale (VAS), the McGill Pain Questionnaire (MPQ), the Health Survey-36 (SF-36), and the Hamilton Depression (HDRS). During treatment there was a significant reduction in the VAS scores favoring the r-rTMS group, mean reduction of 4.65 cm (50.9%) against 2.18 cm (24.7%) in the s-rTMS group. The highest reduction occurred at the tenth session and correlated to improvement in the affective and emotional subscores of the MPQ and SF-36. Real rTMS to the M1 produced analgesic effects and positive changes in affective aspects of pain in CRPS patients during the period of stimulation.
Effects of conditioning peripheral repetitive magnetic stimulation in patients with complex regional pain syndrome. [2019]We tested whether repetitive magnetic stimulation (rMS) induces an afferent input to the spinocerebral tract in patients with complex regional pain syndrome (CRPS).
Graded motor imagery modifies movement pain, cortical excitability and sensorimotor function in complex regional pain syndrome. [2021]Patients with complex regional pain syndrome suffer from chronic neuropathic pain and also show a decrease in sensorimotor performance associated with characteristic central and peripheral neural system parameters. In the brain imaging domain, these comprise altered functional sensorimotor representation for the affected hand side. With regard to neurophysiology, a decrease in intracortical inhibition for the sensorimotor cortex contralateral to the affected hand has been repetitively verified, which might be related to increased primary somatosensory cortex functional activation for the affected limb. Rare longitudinal intervention studies in randomized controlled trials have demonstrated that a decrease in primary somatosensory cortex functional MRI activation coincided with pain relief and recovery in sensorimotor performance. By applying a randomized wait-list control crossover study design, we tested possible associations of clinical, imaging and neurophysiology parameters in 21 patients with complex regional pain syndrome in the chronic stage (>6 months). In more detail, we applied graded motor imagery over 6 weeks to relieve movement pain of the affected upper limb. First, baseline parameters were tested between the affected and the non-affected upper limb side and age-matched healthy controls. Second, longitudinal changes in clinical and testing parameters were associated with neurophysiological and imaging parameters. During baseline short intracortical inhibition, as assessed with transcranial magnetic stimulation, was decreased only for hand muscles of the affected hand side. During movement of the affected limb, primary somatosensory cortex functional MRI activation was increased. Hand representation area size for somatosensory stimulation in functional MRI was smaller on the affected side with longer disease duration. Graded motor imagery intervention but not waiting, resulted in a decrease of movement pain. An increase of somatosensory hand representation size over graded motor imagery intervention was related to movement pain relief. Over graded motor imagery intervention, pathological parameters like the increased primary somatosensory cortex activation during fist movement or decreased short intracortical inhibition were modified in the same way as movement pain and hand performance improved. No such changes were observed during the waiting period. Overall, we demonstrated characteristic changes in clinical, behaviour and neuropathology parameters applying graded motor imagery in patients with upper limb complex regional pain syndrome, which casts light on the effects of graded motor imagery intervention on biomarkers for chronic neuropathic pain.
[Motor cortical representation in patients with complex regional pain syndrome: a TMS study]. [2018]In a group of patients with short- and long-term (chronic) duration of complex regional pain syndrome type I (CRPS I) motor cortical representation was determined, using a transcranial magnetic stimulation (TMS) mapping method. This was done, starting with suprathreshold intensities at the location of the largest MEP amplitude, mapping systematically in all directions. Patients were compared to a group of healthy subjects. In both patient groups we found significantly larger motor cortical representation for the unaffected hand muscles compared to the affected side. This asymmetry was absent in healthy subjects. Such motor cortical representation asymmetry can be considered an effect of altered sensomotor cortical representation. On the other hand, one must also consider the increased use of the unaffected hand and the presence of pain as cortical influencing variables. The real cause must remain speculative at this time.
[Central and peripheral deafferent pain: therapy with repetitive transcranial magnetic stimulation]. [2018]This study evaluates the effects of repeated sessions of low- and high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex on central and phantom limb pain.