rTMS and Rehabilitation for Individuals With CRPS Type 1

State University of New York - Upstate Medical University

Status: Enrolling

Conditions: Complex Regional Pain Syndrome Type I

Treatments: Other: Rehabilitation; Device: Sham Repeated Transcranial Magnetic Stimulation; Device: Repeated Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05745025

1809306-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

rTMS and Rehabilitation

Experimental group

Description:

Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.

Treatment:

Other: Rehabilitation

Device: Repeated Transcranial Magnetic Stimulation

Sham rTMS and Rehabilitation

Sham Comparator group

Description:

Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.

Treatment:

Device: Sham Repeated Transcranial Magnetic Stimulation

Other: Rehabilitation