An interventional study of Repeated Transcranial Magnetic Stimulation and Sham Repeated Transcranial Magnetic Stimulation in Complex Regional Pain Syndrome Type I, sponsored by State University of New York - Upstate Medical University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Treatment
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Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 44th largest by planned enrollment of the 67 interventional ones that give a count, is one of 7 that started in 2023, is one of 36 with no phase, reaches primary completion later than 1 of the 21 other live ones, and was the 71st registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
Browse Complex Regional Pain Syndromes studies →20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Scripps Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 13 · Phase 4 4
First in 2000; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Median enrollment 30 across the 67 interventional studies, 60 across the 21 observational. Of the 56 that completed or were terminated, 29 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 88 have an industry lead sponsor. The 10 most frequent:
State University of New York - Upstate Medical University is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
State University of New York - Upstate Medical University has 1 study filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
8 of the studies in Complex Regional Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06798493Hospital for Special Surgery, New YorkCSS-SR Validation Study | 2026-12-29 |
| NCT05593237University of California, San FranciscoTranscranial Magnetic Stimulation for Chronic Neuropathic Pain | 2026-12-30 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT05777889Hospital for Special Surgery, New YorkInfrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients | 2027-02 |
| NCT05814497Children's Hospital Medical Center, CincinnatiSupraspinal Processing of Sensory Aspects of Pain | 2027-06-30 |
Add all 8 to your calendar (.ics) → With an account.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.
Device: Repeated Transcranial Magnetic Stimulation · Other: Rehabilitation
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
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
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
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
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).
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.
Numeric Pain Rating Scale (NPRS) worse/least pain over 24 hours
Subjects will be asked to rate their highest pain level and lowest pain level over a 24-hour period. (0 indicating no pain and 10 indicating worse possible pain).
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
Patient-Reported Outcomes Measurement Information Systems (PROMIS).
NIH developed computer adaptive tools measuring pain interference, pain behavior, physical functioning, social roles, fatigue, depression, anxiety, and anger. Scores are reported based on T-scores with a mean population score of 50 and a standard deviation of 10. Scores generally range from 20-80. For symptom scales (i.e. pain interference), higher scores indicate worse symptoms, and for function scales (i.e. social roles), higher scores indicate better function.
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
Global Rating of Change (GROC)
Subjects will be asked to rate the change of their symptoms from 7(a great deal better) to -7 (a great deal worse) with 0 being no different.
Time frame: 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)
Subjects will be asked to rate the impact of the change from 7(a great deal better) to -7 (a great deal worse) with 0 being no different.
Time frame: 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)
Patients are asked if their current state of symptoms is acceptable, yes/no
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.
Grip Strength or 1 Rep Leg Press
Subjects with upper extremity involvement will have grip strength measured using a dynamometer. Subjects with lower extremity involvement will be tested with single leg 1 rep max leg press.
Time frame: Sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Feb 2025, 23 months after the start.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 23 months is close to that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Complex Regional Pain Syndromes →
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