Complex Regional Pain Syndrome (CRPS)
Conditions
Brief summary
The purpose of this pilot study is to test the durability of response to Transcranial Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS for varying lengths of time in a pilot study to investigate what the clinical impact.
Interventions
DEVICETranscranial Magnetic Stimulation (TMS)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Diagnosis of CRPS (complex regional pain syndrome) * Average pain level reported on Numerical Rating Scale meets entry criteria * Ability to perform the experimental task and procedures.
Exclusion criteria
* MRI contraindication (metal implants or devices, claustrophobia) * TMS Contraindication (eg metal implant or devices near the site of stimulation) * History of epilepsy * History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. * Neurologic illness that would interfere with brain integrity * Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. * Currently pregnant or planning to become pregnant. * On going legal action or disability claim.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Present Pain Intensity | Baseline, post-treatment, one week follow-up | Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TMS Intervention for 1 Day Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Transcranial Magnetic Stimulation (TMS) | 5 |
| TMS Intervention for 5 Days Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Transcranial Magnetic Stimulation (TMS) | 12 |
| Total | 17 |
Baseline characteristics
| Characteristic | TMS Intervention for 5 Days | TMS Intervention for 1 Day | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 4 Participants | 15 Participants |
| Age, Continuous | 42.92 years STANDARD_DEVIATION 13.69 | 49.8 years STANDARD_DEVIATION 16.47 | 44.94 years STANDARD_DEVIATION 14.39 |
| Region of Enrollment United States | 12 participants | 5 participants | 17 participants |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 15 |
| other Total, other adverse events | 1 / 5 | 10 / 15 |
| serious Total, serious adverse events | 0 / 5 | 0 / 15 |
Outcome results
Primary
Present Pain Intensity
Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.
Time frame: Baseline, post-treatment, one week follow-up
Population: Data from participants who completed the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TMS Intervention (1 Day) | Present Pain Intensity | Baseline | 6.5 Units on a scale | Standard Deviation 2.3 |
| TMS Intervention (1 Day) | Present Pain Intensity | Post-treatment | 3.1 Units on a scale | Standard Deviation 3.1 |
| TMS Intervention (1 Day) | Present Pain Intensity | One week follow-up | 4.6 Units on a scale | Standard Deviation 4 |
| TMS Intervention (5 Days) | Present Pain Intensity | Baseline | 6.3 Units on a scale | Standard Deviation 1.4 |
| TMS Intervention (5 Days) | Present Pain Intensity | Post-treatment | 3.7 Units on a scale | Standard Deviation 3 |
| TMS Intervention (5 Days) | Present Pain Intensity | One week follow-up | 4.3 Units on a scale | Standard Deviation 2.7 |