Dyskinesia, Medication-InducedPhase 2NCT02657681
Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
A Phase 2 study testing tSMS in people with Dyskinesia, Medication-Induced and Parkinson's Disease, run by Fundación de investigación HM at 1 site in Spain.
Trial summary
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyskinesia, Medication-Induced, Parkinson's Disease
- What is being tested?
- tSMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Sep 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced idiopathic Parkinson's disease (Brain Bank criteria)
- optimal clinical response to dopaminergic medication (>30% UPDRS-III improvement)
- presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb
Who cannot join
- MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- other main neuropsychiatric co-morbidity
Trial locations and contacts
1 site in 1 country.
Spain1 site
CINAC, Hospital Universitario Puerta del Sur
Móstoles, Madrid, 28938
About this study
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).
- Being tested
- tSMS, sham
- Medical subject headings
- Dyskinesia, Drug-Induced, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tSMSDevice
Also called MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body.
shamDevice
Also called MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain).
| Study group | Role | What they receive |
|---|---|---|
| tSMS | Experimental | 30 min of tSMS, one session per day, for 9 days over 2 weeks Receives: Device: tSMS |
| sham | Placebo comparator | 30 min of sham, one session per day, for 9 days over 2 weeks Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment.
Measured: One day after the end of treatment compared to baseline
Secondary outcomes (4)
Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment.
Measured: One week after the end of treatment compared to baseline
Dyskinesia severity evaluated for each body segment
Measured: Baseline, one day and one week after the end of treatment
Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)
Measured: One day and one week after the end of treatment
Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale
Measured: Baseline, one day and one week after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyskinesia, Medication-InducedStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Hospital Nacional de Parapléjicos de Toledo, Hospital San Carlos, Madrid
- Responsible party
- Principal investigator, Guglielmo Foffani, Fundación de investigación HM
- Investigators
- Guglielmo Foffani, PhD, Principal investigator, CINAC, Hospital Universitario HM Puerta del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657681
- Sponsor's protocol ID
- MJFOX-9205
- Other IDs
- 9205
- Status last verified
- Oct 2018
- First submitted
- 14 Jan 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
- ClinicalTrials.gov ID
- NCT02657681
- Acronym / sponsor ID
- MJFOX-9205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Hospital Nacional de Parapléjicos de Toledo, Hospital San Carlos, Madrid
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 18 Jan 2016 (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.
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tSMS | Experimental | Device: tSMS30 min of tSMS, one session per day, for 9 days over 2 weeks |
| sham | Placebo comparator | Device: sham30 min of sham, one session per day, for 9 days over 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- advanced idiopathic Parkinson's disease (Brain Bank criteria)
- optimal clinical response to dopaminergic medication (>30% UPDRS-III improvement)
- presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb
Key exclusion criteria (2 listed)
- MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- other main neuropsychiatric co-morbidity
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 |
|---|---|---|
| tSMSAlso: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body. | Device | tSMS |
| shamAlso: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain). | Device | sham |
Primary outcome
Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment.
Time frame: One day after the end of treatment compared to baseline
4 secondary outcomes
Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment.
Time frame: One week after the end of treatment compared to baseline
Dyskinesia severity evaluated for each body segment
Time frame: Baseline, one day and one week after the end of treatment
Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)
Time frame: One day and one week after the end of treatment
Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale
Time frame: Baseline, one day and one week after the end of treatment
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 11 Oct 2018.
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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.
Guglielmo Foffani, PhD principal investigator
CINAC, Hospital Universitario HM Puerta del Sur
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 tSMS in people with Dyskinesia, Medication-Induced and Parkinson's Disease, run by Fundación de investigación HM at 1 site in Spain.
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 2 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 11 Oct 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 Spain. 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.
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 from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment. (time frame: One day after the end of treatment compared to baseline). 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 11 Oct 2018.