Clinical trial NCT05745025: rTMS and Rehabilitation for Individuals With CRPS Type 1
Official title: Repeated Transcranial Magnetic Stimulation and Rehabilitation for Individuals With Complex Regional Pain Syndrome Type 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)
First posted: 2023-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Subjects will be randomized to receive either real or sham rTMS, combined with rehabilitation. Subjects will attend 10 sessions over 4 weeks.

rTMS will be delivered at 10Hz using an intensity of 80% of the motor threshold. Pulse trains will be delivered for 10 seconds, with a 30-second rest for 20 repetitions. This will result in a total of 2,000 pulses of magnetic stimulation and will take approximately 20 minutes. There will be 10 rTMS sessions over the 4 weeks.

Sham rTMS will be delivered using the same method as rTMS, but a sham coil, that does not deliver magnetic stimulation, will be used.

Rehabilitation will include graded motor imagery, education, and graded functional activity. There will be 8 rehabilitation sessions over 4 weeks.

Outcomes will include questionnaires asking about pain and function, and either grip strength or leg press strength measurements.

Eligibility criteria: Inclusion Criteria:

* Upper or lower extremity CRPS Type 1 (also called RSD-Reflex Sympathetic Dystrophy) of at least 6 months.
* Pain rating on NPRS of at least 4/10
* No initiation of a new intervention (i.e., medication, rehab, injections) in the previous 2 months.
* No plan to initiate a new intervention during the study treatment timeframe (4 weeks).

Exclusion Criteria:

* A history of seizures or epilepsy
* Intracranial metallic devices
* Pacemaker
* Intrathecal infusion pumps
* Brain or spinal cord stimulators with epidural electrodes
* Other ferromagnetic metallic intracranial implants
* Apparent mental or psychiatric disorder that prevents adequate informed consent
* Current pregnancy
* Non-English speaking

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS) Weekly Average
timeFrame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session.
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS) worse/least pain over 24 hours
timeFrame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session
measure: Patient-Reported Outcomes Measurement Information Systems (PROMIS).
timeFrame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session
measure: Global Rating of Change (GROC)
timeFrame: Sessions 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session
measure: Global Rating of Change Impact (GROCi)
timeFrame: Sessions 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4) Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). Surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session.
measure: Grip Strength or 1 Rep Leg Press
timeFrame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4).
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical Univeristy Institute of Human Performance
state: New York
Study officials:
affiliation: SUNY Upstate Medical Univerity
name: Adam Rufa, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.
citation: Gaertner M, Kong JT, Scherrer KH, Foote A, Mackey S, Johnson KA. Advancing Transcranial Magnetic Stimulation Methods for Complex Regional Pain Syndrome: An Open-Label Study of Paired Theta Burst and High-Frequency Stimulation. Neuromodulation. 2018 Jun;21(4):409-416. doi: 10.1111/ner.12760. Epub 2018 Mar 4.
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