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

Study Overview
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Brief Summary
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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
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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

Official Title
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Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: rTMS with H-coil
* Device: rTMS with H-coil
* Device: rTMS with H-coil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS stimulation over M1 and PFC<br> | Device: rTMS with H-coil<br>* Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC<br>|
| Active Comparator: Real rTMS stimulation over M1 and sham rTMS over PFC<br> | Device: rTMS with H-coil<br>* Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC<br>|
| Sham Comparator: Sham rTMS over M1 and PFC<br> | Device: rTMS with H-coil<br>* Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | End of treatment (1 month after start of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change at Pegboard test over time |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment) |