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

NCT04638777 | Completed

• 1 other identifier: rTMS-PD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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)

Study Arms (3)

Real rTMS stimulation over M1 and PFC

ACTIVE COMPARATOR

Device: rTMS with H-coil

Real rTMS stimulation over M1 and sham rTMS over PFC

ACTIVE COMPARATOR

Device: rTMS with H-coil

Sham rTMS over M1 and PFC

SHAM COMPARATOR

Device: rTMS with H-coil

Interventions

rTMS with H-coil DEVICE

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

Real rTMS stimulation over M1 and PFC

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giancarlo Comi: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Giancarlo Comi, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 20, 2020
• Study Start: September 27, 2010
• Primary Completion: June 8, 2012
• Study Completion: July 2, 2012
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: data are available from the corresponding author, upon reasonable request

Locations

IT (1)