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Completed

NCT Number: NCT04638777

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

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.

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Key information

Conditions

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

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele

Milan, MI, 20132, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS with H-coil

Device

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

Primary outcomes

  1. Change at Unified Parkinson's disease rating scale III 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)

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

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

    Time frame: End of treatment (1 month after start of the treatment)

    monitoring presence of side effects due to the stimulation

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Giancarlo Comi

Other

Registry information

Official study title

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

Acronym: rTMS-PD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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