PainNCT03504748
Deep rTMS in Parkinson Disease Pain Syndromes
A study testing deep rTMS in people with Pain and Parkinson Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Parkinson Disease
- What is being tested?
- deep rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson disease
- Signed term of informed consent
- Parkinsson disease related pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
São Paulo, São Paulo, 05403900
Daniel MD Ciampi, Phd, + 55 11 997753538, ciampi@usp.br
About this study
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.
- Conditions
- Pain, Parkinson Disease
- Being tested
- deep rTMS, placebo deep rTMS
- Keywords
- deep repetitive transcranial magnetic stimulation, chronic pain, parkinson, treatment, non-motor symptom
- Medical subject headings
- Pain, Parkinson Disease, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep rTMSDevice
placebo deep rTMSDevice
| Study group | Role | What they receive |
|---|---|---|
| deep rTMS-active doble coil | Active comparator | patients undergoing of deep rTMS real with doble coil Receives: Device: deep rTMS |
| deep rTMS-sham | Sham comparator | patients undergoing to placebo deep rTMS Receives: Device: placebo deep rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start20 Jul 2015
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504748
- Sponsor's protocol ID
- VRBDCA
- Status last verified
- May 2018
- First submitted
- 12 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep rTMS in Parkinson Disease Pain Syndromes
- ClinicalTrials.gov ID
- NCT03504748
- Acronym / sponsor ID
- VRBDCA
- Conditions
- Pain, Parkinson Disease
- Keywords
- deep repetitive transcranial magnetic stimulation, chronic pain, parkinson, treatment, non-motor symptom
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep rTMS-active doble coil | Active comparator | Device: deep rTMSpatients undergoing of deep rTMS real with doble coil |
| deep rTMS-sham | Sham comparator | Device: placebo deep rTMSpatients undergoing to placebo deep rTMS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson disease
- Signed term of informed consent
- Parkinsson disease related pain
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| deep rTMS | Device | deep rTMS-active doble coil |
| placebo deep rTMS | Device | deep rTMS-sham |
Primary outcome
Change in baseline of Pain
Time frame: base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Related trials for Pain
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep rTMS in people with Pain and Parkinson Disease, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 May 2018. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel MD Ciampi, Phd (+ 55 11 997753538, ciampi@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline of Pain (time frame: base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)). 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 8 May 2018.