Complex Regional Pain Syndrome (CRPS)NCT01926119
TMS for CRPS - Pilot Study
A study testing Transcranial Magnetic Stimulation in people with Complex Regional Pain Syndrome (CRPS), run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome (CRPS)
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
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.
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| TMS Intervention - 5 days | Experimental | Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
Measured: Baseline to post-TMS day 5
Secondary outcomes (6)
Change in Motor Function and Coordination
As assessed by functional capacity exam and physical exam
Measured: End of 5-day treatment series and at 1-week follow-up relative to baseline
Change in Sensory Perception
Measured: End of each treatment session and at 1-week follow-up as compared to baseline
Change in Vasomotor Function
Measured: End of each treatment session and at 1-week follow-up as compared to baseline
Change in Sudomotor Function
Measured: End of each treatment session and at 1-week follow-up as compared to baseline
Trophic Changes
Measured: End of each treatment session and at 1-week follow-up as compared to baseline
Change in Motor Strength and Joint Range of Motion
Measured: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complex Regional Pain Syndrome (CRPS)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mackey, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926119
- Sponsor's protocol ID
- 25894
- Status last verified
- Mar 2017
- First submitted
- 16 Aug 2013
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS for CRPS - Pilot Study
- ClinicalTrials.gov ID
- NCT01926119
- Acronym / sponsor ID
- 25894
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS Intervention - 5 days | Experimental | Device: Transcranial Magnetic StimulationApplication of Transcranial Magnetic Stimulation (TMS) once per day over 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation | Device | TMS Intervention - 5 days |
Primary outcome
Change in Pain
Time frame: Baseline to post-TMS day 5
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
6 secondary outcomes
Change in Motor Function and Coordination
Time frame: End of 5-day treatment series and at 1-week follow-up relative to baseline
Change in Sensory Perception
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Change in Vasomotor Function
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Change in Sudomotor Function
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
Trophic Changes
Time frame: End of each treatment session and at 1-week follow-up as compared to baseline
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Complex Regional Pain Syndrome (CRPS), run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline to post-TMS day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.