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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: rTMS with H-coil; Device: rTMS with H-coil; Device: rTMS with H-coil

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • IRCCS San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Giancarlo Comi
• Investigators: Principal Investigator: Giancarlo Comi, MD, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2010
• Primary Completion (Actual): June 8, 2012
• Study Completion (Actual): July 2, 2012

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: rTMS-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: data are available from the corresponding author, upon reasonable request
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No