Parkinson's DiseasePhase 2rTMSNCT01275573
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients:
- Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- Parkinson's disease patients with a score≤3 on the Hoehn and Year scale
- Patients treated with dopaminergic antiparkinsonian drugs (L-DOPA, dopamine agonists,ICOMT…)
- Patients with or without neuropathic pain induced by Parkinson's disease
- Patients without personal or familial epilepsy episode history
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- Patients from 50 to 80 years old (male or female)
- Patients affiliated to a social protection program
- Patient with an informed consent given
- For Healthy volunteers
- Subjects from 50 to 80 years old (male or female)
- Subjects without any serious evolutionary pathology or any clinical significant treatment
- Subjects without chronic pain or disease which can induce neuropathic pain
- Subjects without personal or familial epilepsy episode history
- Subjects affiliated to a social protection program
- Subjects with an informed consent given
Who cannot join
- For patients:
- Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…)
- Parkinson's disease patients with a score>3 on the Hoehn and Yahr scale
- Patients with important tremors during a OFF conditions
- Patients suffering from a cancer
- Patients with a neuroleptic treatment
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- Patients under tutelage, curatella or law protection
- Patients included in an other clinical study
- Patients unable to fulfil scales of the study
- Patients with personal or familial epilepsy episode history
- Contraindication of IRM
- Pregnant women
- For Healthy volunteers:
- Subjects with serious evolutionary pathology or any clinical significant treatment
- Subjects with chronic pain or disease which can induce neuropathic pain
- Subjects with personal or familial epilepsy episode history
- Contraindication of IRM
- Pregnant women
- Subjects under tutelage, curatella or law protection
- Subjects included in an other clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study
Pain is a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.
The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.
- Conditions
- Parkinson's Disease
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, pain threshold, Parkinson's disease, Pain threshold in Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called non applicable
Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| painful Parkinson's disease patients | Other | All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| painless Parkinson's disease patients | Other | All the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Measured: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Secondary outcomes (3)
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Measured: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
- Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Measured: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Mood assessment using Visual Analogue Scale
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
Measured: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Brefel-Courbon, MD, Principal investigator, Toulouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275573
- Sponsor's protocol ID
- 09 155 02
- Acronym
- rTMS
- Status last verified
- Jun 2013
- First submitted
- 10 Dec 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency rTMS (Repetitive Transcranial Magnetic Stimulation) Effect Applied on Primary Cortical Motor, on Nociceptive Perception Thresholds in Parkinson's Disease Patients: a Physiopathology Study
- ClinicalTrials.gov ID
- NCT01275573
- Acronym / sponsor ID
- rTMS / 09 155 02
- Conditions
- Parkinson's Disease
- Keywords
- Repetitive Transcranial Magnetic Stimulation, pain threshold, Parkinson's disease, Pain threshold in Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Jan 2011 (estimated)
- 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 a frequent symptom in Parkinson's disease. Previous studies have shown that pain perception was altered in Parkinson's disease patients and could be related to nociceptive cortical area hyperactivation. Repetitive Transcranial Magnetic Stimulation is an electrophysiological tool which can modify cortical excitability. Its efficacy was demonstrated in neuropathic pain. This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients. Each group will receive a high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation in different order with a gap of one week.
The investigators supposed that a 20 Hz Repetitive Transcranial Magnetic Stimulation session with an infraliminary intensity on the primary cortical motor, modulating nociceptive cortical areas activity, could modify the nociceptive threshold perception in Parkinson's patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Device: Repetitive Transcranial Magnetic StimulationAll the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation |
| painful Parkinson's disease patients | Other | Device: Repetitive Transcranial Magnetic StimulationAll the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation |
| painless Parkinson's disease patients | Other | Device: Repetitive Transcranial Magnetic StimulationAll the patients and healthy volunteers will receive high frequency Repetitive Transcranial Magnetic Stimulation and placebo stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- Parkinson's disease patients with a score≤3 on the Hoehn and Year scale
- Patients treated with dopaminergic antiparkinsonian drugs (L-DOPA, dopamine agonists,ICOMT…)
- Patients with or without neuropathic pain induced by Parkinson's disease
- Patients without personal or familial epilepsy episode history
Key exclusion criteria (20 listed)
- Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…)
- Parkinson's disease patients with a score>3 on the Hoehn and Yahr scale
- Patients with important tremors during a OFF conditions
- Patients suffering from a cancer
- Patients with a neuroleptic treatment
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: non applicableRepetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold. | Device | healthy volunteers, painful Parkinson's disease patients, painless Parkinson's disease patients |
Primary outcome
Change of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Change from baseline after each Repetitive Transcranial Magnetic Stimulation session (active and placebo)
3 secondary outcomes
Analgesic effect of Repetitive Transcranial Magnetic Stimulation using Visual Analogue Scale
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
- Clinical evaluation of the severity of the motor handicap of patients using Unified's Parkinson's Disease Rating Scale (UPDRSIII)
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Mood assessment using Visual Analogue Scale
Time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Christine Brefel-Courbon, MD principal investigator
Toulouse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease, run by University Hospital, Toulouse at 1 site in France.
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 16 inclusion and 20 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 19 Jun 2013. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels after rTMS session (time frame: D1 T0, D1 T1h30mn, D7 T0, D7 T1h30mn). 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 19 Jun 2013.