Parkinson DiseaserTMS-PDNCT04638777
Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD)
A study testing rTMS with H-coil in people with Parkinson Disease, run by Giancarlo Comi at 1 site in Italy.
Trial summary
Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- rTMS with H-coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2010to 2 Jul 2012
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects aged ≤80 years
- Diagnosis of Parkinson's disease according to UK Brain Bank criteria
- Hoehn and Yahr (HY) scale II-IV
- Stable anti-depressive and anti-parkinsonian therapy for at least two months prior to enrollment
- Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner.
- Have given written informed consent
Who cannot join
- Presence of an additional neurological or psychiatric pathology
- Severe personality disorder
- Uncontrolled hypertension.
- History of epilepsy, seizures, febrile convulsions.
- History of epilepsy or seizures in first degree relatives.
- History of head injury or stroke.
Show all 13Show fewer
- Presence of metal prostheses in the head (except dental fillings).
- Metal implants or known history of any metal particles in the eye, cardiac pacemakers, cochlear implants, use of neurostimulators or medical pumps.
- History of migraine within the past six months.
- History of drug or alcohol abuse.
- Impossibility of adequate communication with the examiner.
- Participation in another clinical study, either concomitant or within the previous 3 months.
- Inability to sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study
Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential efficacy of the treatment. In this study the investigators aimed to explore the safety and efficacy of excitatory rTMS with H-coil on PD motor symptoms.
Read the detailed description
This was a double-blind, placebo-controlled study, with a 1:1:1 randomization into three groups: group 1 - real rTMS over primary motor cortex and prefrontal cortex (M1-PFC): group 2 - real rTMS over M1 and sham rTMS over PFC; group 3 - sham stimulation over both targets
- Conditions
- Parkinson Disease
- Being tested
- rTMS with H-coil
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS with H-coilDevice
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
rTMS with H-coilDevice
Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
rTMS with H-coilDevice
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS stimulation over M1 and PFC | Active comparator | Not described Receives: Device: rTMS with H-coil |
| Real rTMS stimulation over M1 and sham rTMS over PFC | Active comparator | Not described Receives: Device: rTMS with H-coil |
| Sham rTMS over M1 and PFC | Sham comparator | Not described Receives: Device: rTMS with H-coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change at Unified Parkinson's disease rating scale III over time
A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
monitoring presence of side effects due to the stimulation
Measured: End of treatment (1 month after start of the treatment)
Secondary outcomes (8)
Change at Pegboard test over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Tapping test over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Up & Go Test over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at dyskinesia rating scale over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at and at Word Fluency test over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Digit forward & backward test over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Beck Depression Inventory scale-II over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at The Clinical Global Impression - Severity scale ( CGI-S) over time
Measured: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start27 Sep 2010
- Primary completion8 Jun 2012
- Study completion2 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giancarlo Comi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giancarlo Comi, IRCCS San Raffaele
- Investigators
- Giancarlo Comi, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638777
- Sponsor's protocol ID
- rTMS-PD
- Acronym
- rTMS-PD
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04638777
- Acronym / sponsor ID
- rTMS-PD / rTMS-PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Giancarlo ComiUniversity, hospital or other
- Study start
- 27 Sep 2010 (actual)
- Primary completion
- 8 Jun 2012 (actual)
- Study completion
- 2 Jul 2012 (actual)
- First posted
- 20 Nov 2020 (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.
Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential efficacy of the treatment. In this study the investigators aimed to explore the safety and efficacy of excitatory rTMS with H-coil on PD motor symptoms.
Detailed description
This was a double-blind, placebo-controlled study, with a 1:1:1 randomization into three groups: group 1 - real rTMS over primary motor cortex and prefrontal cortex (M1-PFC): group 2 - real rTMS over M1 and sham rTMS over PFC; group 3 - sham stimulation over both targets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real rTMS stimulation over M1 and PFC | Active comparator | Device: rTMS with H-coil |
| Real rTMS stimulation over M1 and sham rTMS over PFC | Active comparator | Device: rTMS with H-coil |
| Sham rTMS over M1 and PFC | Sham comparator | Device: rTMS with H-coil |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged ≤80 years
- Diagnosis of Parkinson's disease according to UK Brain Bank criteria
- Hoehn and Yahr (HY) scale II-IV
- Stable anti-depressive and anti-parkinsonian therapy for at least two months prior to enrollment
- Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner.
Key exclusion criteria (13 listed)
- Presence of an additional neurological or psychiatric pathology
- Severe personality disorder
- Uncontrolled hypertension.
- History of epilepsy, seizures, febrile convulsions.
- History of epilepsy or seizures in first degree relatives.
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 |
|---|---|---|
| rTMS with H-coilReal repetitive transcranial magnetic stimulation with H-coil over M1 and PFC | Device | Real rTMS stimulation over M1 and PFC |
| rTMS with H-coilReal repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC | Device | Real rTMS stimulation over M1 and sham rTMS over PFC |
| rTMS with H-coilSham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC | Device | Sham rTMS over M1 and PFC |
Primary outcome
Change at Unified Parkinson's disease rating scale III over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's
Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
Time frame: End of treatment (1 month after start of the treatment)
monitoring presence of side effects due to the stimulation
8 secondary outcomes
Change at Pegboard test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Tapping test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Up & Go Test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at dyskinesia rating scale over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at and at Word Fluency test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Digit forward & backward test over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at Beck Depression Inventory scale-II over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Change at The Clinical Global Impression - Severity scale ( CGI-S) over time
Time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the 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 20 Nov 2020.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Giancarlo Comi, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS with H-coil in people with Parkinson Disease, run by Giancarlo Comi at 1 site in Italy.
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 6 inclusion and 13 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 20 Nov 2020. 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 Italy. 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?
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 at Unified Parkinson's disease rating scale III over time (time frame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)). The study lists 2 primary outcomes in all. 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 20 Nov 2020.