Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD)

Giancarlo Comi

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: rTMS with H-coil

Study type

Interventional

Funder types

Other

Identifiers

NCT04638777

rTMS-PD

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

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.