Recruiting

rTMS & Rehabilitation

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT05745025

Conditions

Complex Regional Pain Syndrome Type I

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Repeated Transcranial Magnetic Stimulation

Sham Repeated Transcranial Magnetic Stimulation

Rehabilitation

Study Details

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.

Conditions

Complex Regional Pain Syndrome Type I

Study ID

NCT05745025

Start date

Feb 28, 2023

Status verified date

Aug, 2023

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS and Rehabilitation

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

sham comparator: Sham rTMS and Rehabilitation

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

Interventions

Repeated Transcranial Magnetic Stimulation

rTMS will be delivered using a commercially available magnetic stimulator (Rapid2, Magstim Inc., Eden Prairie, MN) with a figure-of-8 Air Film coil at 10 Hz. Coil orientation will be optimized for stimulation of the abductor pollicis brevis. Stimulation targeting will be identified using motor-evoked potentials (MEP) of the first dorsal interossei that will be monitored using electromyography (EMG) (Motion Lab Systems Inc., Baton Rouge, LA). The motor threshold (MT) of the muscle will then be identified by systematically adjusting the pulse intensity. The MT will be considered the lowest stimulation intensity at which 5 out of 10 MEPs have a peak-to-peak amplitude of at least 50 microvolts. rTMS will be performed at the identified optimal location at 10Hz using an intensity that is 80% of the MT. Pulse trains will be delivered for 10 seconds, with a 30-second rest for 20 repetitions.

Sham Repeated Transcranial Magnetic Stimulation

Sham rTMS will be performed using the same methods as the active group, but a sham Air Film coil (Magstim Inc., Eden Prairie, MN) will be used. This coil looks and sounds like the active coil, but it does not deliver magnetic pulses.

Rehabilitation

Rehabilitation will consist of education, value-based goal setting, Graded Motor Imagery (GMI) (3 components described below), and graded activity. Subjects will complete activities at treatment sessions and be asked to perform certain treatment activities at home.

Week 1: Pain education, functional value-based goal setting, laterality training (first component of GMI), one task for graded activity (task-based on patient goals)

Week 2: Continue week 1 activity, add graded motor imagery (second component of GMI), progress 1st graded activity, and initiate 2nd graded activity exercise.

Week 3- Mirror therapy (third component of GMI), assess knowledge and update education as needed, progress graded activity 1 and 2, and add 3rd graded activity if appropriate based on patient goals.

Week 4- Continue with week 3 activities. Discuss experience with meditation and progress graded activity as tolerated

Primary outcome measure

  • Numeric Pain Rating Scale (NPRS) Weekly Average [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Adam P Rufa, DPT, PhD

(315)464-6883rufaa@upstate.edu

Locations

SUNY Upstate Medical Univeristy Institute of Human Performance

Recruiting

Syracuse, New York, United States, 13210

Contacts

Adam p Rufa, DPT, PhD

315-464-6883rufaa@upstate.edu

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Aug 30, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2023-08-30.