rTMS and Rehabilitation for Individuals With CRPS Type 1

NCT05745025 | Unknown FDA Device

• 1 other identifier: 1809306-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS) Weekly Average

  Subjects will be asked to rate their weekly average pain on a scale from 0-10 (0 indicating no pain and 10 indicating worse possible pain).

  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 (6)

• Numeric Pain Rating Scale (NPRS) worse/least pain over 24 hours

  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

• Patient-Reported Outcomes Measurement Information Systems (PROMIS).

  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

• Global Rating of Change (GROC)

  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

• Global Rating of Change Impact (GROCi)

  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

• Patient Acceptable Symptom State (PASS)

  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.

Study Arms (2)

rTMS and Rehabilitation

EXPERIMENTAL

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

Device: Repeated Transcranial Magnetic Stimulation; Other: Rehabilitation

Sham rTMS and Rehabilitation

SHAM COMPARATOR

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

Device: Sham Repeated Transcranial Magnetic Stimulation; Other: Rehabilitation

Interventions

Repeated Transcranial Magnetic Stimulation DEVICE

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.

Also known as: rTMS

rTMS and Rehabilitation

Sham Repeated Transcranial Magnetic Stimulation DEVICE

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.

Also known as: SrTMS

Sham rTMS and Rehabilitation

Rehabilitation OTHER

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

Sham rTMS and Rehabilitation; rTMS and Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Reflex Sympathetic Dystrophy Syndrome Association (RSDSA): collaborator

Study Sites (1)

SUNY Upstate Medical Univeristy Institute of Human Performance

Syracuse, New York, 13210, United States

RECRUITING

Related Publications (6)

• Shafiee E, MacDermid J, Packham T, Walton D, Grewal R, Farzad M. The Effectiveness of Rehabilitation Interventions on Pain and Disability for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis. Clin J Pain. 2023 Feb 1;39(2):91-105. doi: 10.1097/AJP.0000000000001089.

  PMID: 36650605 BACKGROUND

• Eldufani J, Elahmer N, Blaise G. A medical mystery of complex regional pain syndrome. Heliyon. 2020 Feb 19;6(2):e03329. doi: 10.1016/j.heliyon.2020.e03329. eCollection 2020 Feb.

  PMID: 32149194 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 BACKGROUND

• 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.

  PMID: 20430702 BACKGROUND

• 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.

  PMID: 29504190 BACKGROUND

• Pleger B, Janssen F, Schwenkreis P, Volker B, Maier C, Tegenthoff M. Repetitive transcranial magnetic stimulation of the motor cortex attenuates pain perception in complex regional pain syndrome type I. Neurosci Lett. 2004 Feb 12;356(2):87-90. doi: 10.1016/j.neulet.2003.11.037.

  PMID: 14746870 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Adam Rufa, DPT, PhD

  SUNY Upstate Medical Univerity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam P Rufa, DPT, PhD

CONTACT

(315)464-6883; rufaa@upstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, providers of physical therapy, primary investigator, and outcome assessor will be blinded to group allocation. The provider delivering the rTMS will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: February 28, 2023
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)