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

NCT ID: NCT04638777

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-27

Study Completion Date

2012-07-02

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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Real rTMS stimulation over M1 and PFC

Group Type ACTIVE_COMPARATOR

rTMS with H-coil

Intervention Type DEVICE

Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Real rTMS stimulation over M1 and sham rTMS over PFC

Group Type ACTIVE_COMPARATOR

rTMS with H-coil

Intervention Type DEVICE

Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC

Sham rTMS over M1 and PFC

Group Type SHAM_COMPARATOR

rTMS with H-coil

Intervention Type DEVICE

Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Interventions

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rTMS with H-coil

Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Intervention Type DEVICE

rTMS with H-coil

Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC

Intervention Type DEVICE

rTMS with H-coil

Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Intervention Type DEVICE

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.
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Giancarlo Comi

OTHER

Sponsor Role lead

Responsible Party

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Giancarlo Comi

MD, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Giancarlo Comi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

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IRCCS San Raffaele

Milan, MI, Italy

Site Status

Countries

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Italy

Other Identifiers

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rTMS-PD

Identifier Type: -

Identifier Source: org_study_id