Clinical trial NCT04638777: Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD)
Official title: Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 60
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change at Unified Parkinson's disease rating scale III over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
timeFrame: End of treatment (1 month after start of the treatment)
Secondary outcomes:
measure: Change at Pegboard test over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at Tapping test over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at Up & Go Test over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at dyskinesia rating scale over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at and at Word Fluency test over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at Digit forward & backward test over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at Beck Depression Inventory scale-II over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
measure: Change at The Clinical Global Impression - Severity scale ( CGI-S) over time
timeFrame: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
state: MI
Study officials:
affiliation: IRCCS San Raffaele
name: Giancarlo Comi, MD
role: PRINCIPAL_INVESTIGATOR
References: