Deep rTMS in Parkinson Disease Pain Syndromes
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jul 2015
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2015
CompletedFirst Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 8, 2018
May 1, 2018
3 years
April 12, 2018
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
deep rTMS-active doble coil
ACTIVE COMPARATORpatients undergoing of deep rTMS real with doble coil
deep rTMS-sham
SHAM COMPARATORpatients undergoing to placebo deep rTMS
Interventions
Eligibility Criteria
You may qualify if:
- Parkinson disease
- Signed term of informed consent
- Parkinsson disease related pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
São Paulo, São Paulo, 05403900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD (Head of Pain Division)
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 20, 2018
Study Start
July 20, 2015
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05