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The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS Intervention - 5 days | Experimental | Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable | Baseline to post-TMS day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Function and Coordination | As assessed by functional capacity exam and physical exam | End of 5-day treatment series and at 1-week follow-up relative to baseline |
| Change in Sensory Perception |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS Intervention - 5 Days | Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TMS Intervention - 5 Days | Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain | Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable | Completed 5 days of TMS | Posted | Mean | Full Range | units on a scale | Baseline to post-TMS day 5 |
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Participants were followed during 5 days of treatment and for 1 week following treatment
Participants were assessed for pain before and after each treatment session and at 1 week follow-up. During these assessments adverse events were evaluated as well.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMS Intervention - 5 Days | Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | participants reported headache after stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Johnson, PhD RN | Stanford University | (650) 721-1988 | johnsk@stanford.edu |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| End of each treatment session and at 1-week follow-up as compared to baseline |
| Change in Vasomotor Function | End of each treatment session and at 1-week follow-up as compared to baseline |
| Change in Sudomotor Function | End of each treatment session and at 1-week follow-up as compared to baseline |
| Trophic Changes | End of each treatment session and at 1-week follow-up as compared to baseline |
| Change in Motor Strength and Joint Range of Motion | End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Change in Motor Function and Coordination | As assessed by functional capacity exam and physical exam | This data was not collected and was therefore not analyzed. | Posted | End of 5-day treatment series and at 1-week follow-up relative to baseline |
|
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| Secondary | Change in Sensory Perception | This data was not collected and therefore not analyzed. | Posted | End of each treatment session and at 1-week follow-up as compared to baseline |
|
|
| Secondary | Change in Vasomotor Function | This data was not collected and therefore not analyzed. | Posted | End of each treatment session and at 1-week follow-up as compared to baseline |
|
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| Secondary | Change in Sudomotor Function | This data was not collected and therefore not analyzed. | Posted | End of each treatment session and at 1-week follow-up as compared to baseline |
|
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| Secondary | Trophic Changes | This data was not collected and therefore not analyzed. | Posted | End of each treatment session and at 1-week follow-up as compared to baseline |
|
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| Secondary | Change in Motor Strength and Joint Range of Motion | This data was not collected and therefore not analyzed. | Posted | End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline |
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| 0 |
| 4 |
| 3 |
| 4 |
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| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment | participants reported nausea and vomiting 6-8 hours after treatment |
|
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