Complex Regional Pain Syndrome (CRPS)
Conditions
Brief summary
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.
Interventions
DEVICETranscranial Magnetic Stimulation
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Diagnosis of CRPS (complex regional pain syndrome) 3. Average pain level reported on Numerical Rating Scale meets entry criteria 4. Ability to perform the experimental task and procedures.
Exclusion criteria
1. MRI contraindication (metal implants or devices, claustrophobia) 2. TMS Contraindication (eg metal implant or devices near the site of stimulation) 3. History of epilepsy 4. History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. 5. Neurologic illness that would interfere with brain integrity 6. Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. 7. Currently pregnant or planning to become pregnant. 8. On going legal action or disability claim.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline to post-TMS day 5 | Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sensory Perception | 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 Motor Function and Coordination | End of 5-day treatment series and at 1-week follow-up relative to baseline | As assessed by functional capacity exam and physical exam |
| 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 | — |
| Change in Sudomotor Function | End of each treatment session and at 1-week follow-up as compared to baseline | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TMS Intervention - 5 Days |
|---|---|
| Age, Continuous | 55.5 years |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Change in Pain
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
Time frame: Baseline to post-TMS day 5
Population: Completed 5 days of TMS
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TMS Intervention - 5 Days | Change in Pain | Baseline NRS | 5.2 units on a scale |
| TMS Intervention - 5 Days | Change in Pain | Post-TMS day 5 NRS | 0.7 units on a scale |
Secondary
Change in Motor Function and Coordination
As assessed by functional capacity exam and physical exam
Time frame: End of 5-day treatment series and at 1-week follow-up relative to baseline
Population: This data was not collected and was therefore not analyzed.
Secondary
Change in Motor Strength and Joint Range of Motion
Time frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline
Population: This data was not collected and therefore not analyzed.
Secondary
Change in Sensory Perception
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Population: This data was not collected and therefore not analyzed.
Secondary
Change in Sudomotor Function
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Population: This data was not collected and therefore not analyzed.
Secondary
Change in Vasomotor Function
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Population: This data was not collected and therefore not analyzed.
Secondary
Trophic Changes
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Population: This data was not collected and therefore not analyzed.