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

Parkinson Disease Clinical Trial

— rTMS-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638777
• Other study ID #: rTMS-PD
• Status: Completed
• Phase: N/A
• Start date: September 27, 2010
• Est. completion date: July 2, 2012

Study information

• Verified date: November 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2, 2012
• Est. primary completion date: June 8, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• rTMS with H-coil
Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
• 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
• rTMS with H-coil
Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Giancarlo Comi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)