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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

rTMS with H-coil

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

IRCCS San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS stimulation over M1 and PFC

Real rTMS stimulation over M1 and sham rTMS over PFC

Sham rTMS over M1 and PFC

Arm Description

Outcomes

Primary Outcome Measures

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

Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]

monitoring presence of side effects due to the stimulation

Secondary Outcome Measures

Change at Pegboard test over time

Change at Tapping test over time

Change at Up & Go Test over time

Change at dyskinesia rating scale over time

Change at and at Word Fluency test over time

Change at Digit forward & backward test over time

Change at Beck Depression Inventory scale-II over time

Change at The Clinical Global Impression - Severity scale ( CGI-S) over time

Full Information

NCT ID

NCT04638777

First Posted

November 5, 2020

Last Updated

November 16, 2020

Sponsor

Giancarlo Comi

1. Study Identification

Unique Protocol Identification Number

NCT04638777

Brief Title

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

Acronym

rTMS-PD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 27, 2010 (Actual)

Primary Completion Date

June 8, 2012 (Actual)

Study Completion Date

July 2, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Giancarlo Comi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real rTMS stimulation over M1 and PFC

Arm Type

Active Comparator

Arm Title

Real rTMS stimulation over M1 and sham rTMS over PFC

Arm Type

Active Comparator

Arm Title

Sham rTMS over M1 and PFC

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

rTMS with H-coil

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

rTMS with H-coil

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

rTMS with H-coil

Intervention Description

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

Primary Outcome Measure Information:

Title

Change at Unified Parkinson's disease rating scale III over time

Description

A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]

Description

monitoring presence of side effects due to the stimulation

Time Frame

End of treatment (1 month after start of the treatment)

Secondary Outcome Measure Information:

Title

Change at Pegboard test over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at Tapping test over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at Up & Go Test over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at dyskinesia rating scale over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at and at Word Fluency test over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at Digit forward & backward test over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at Beck Depression Inventory scale-II over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

Title

Change at The Clinical Global Impression - Severity scale ( CGI-S) over time

Time Frame

Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giancarlo Comi, MD

Organizational Affiliation

IRCCS San Raffaele

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS San Raffaele

City

Milan

State/Province

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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