Pain Clinical Trial
Official title:
Deep rTMS in Parkinson Disease Pain Syndromes
NCT number | NCT03504748 |
Other study ID # | VRBDCA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 20, 2015 |
Est. completion date | December 2018 |
Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Parkinson disease - Signed term of informed consent - Parkinsson disease related pain Exclusion Criteria: - Trauma of Skull, epilepsy don't treated - Use of medications decrease the seizure threshold - Patients in use of drugs, how cocaine and alcohol - neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure) - Pregnant or lacting women - Moderate or severe cognitive impairment |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP) | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in baseline of Pain | assessing by Visual Analog Scale for Pain (VAS). This scale range from 0 (no pain) to 10 (maximum pain), being considered an effective improvement in the patient's pain when the pain decreases at least in 30% from the basal score. | base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months) |
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