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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real rTMS stimulation over M1 and PFC | Active Comparator |
| |
| Real rTMS stimulation over M1 and sham rTMS over PFC | Active Comparator |
| |
| Sham rTMS over M1 and PFC | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS with H-coil | Device | Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Comi, MD | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | MI | 20132 | Italy |
all IPD that underlie results in a publication
starting 6 months after publication
data are available from the corresponding author, upon reasonable request
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| rTMS with H-coil | Device | Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC |
|
| rTMS with H-coil | Device | Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC |
|
| 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) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |