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Completed

NCT Number: NCT04562506

Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease

Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele

Milan, MI, 20132, Italy

About this study

Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to understand the purpose and risk of the study and provide signed and dated informed consent.
  • Male or female subjects, 18 to 80 years old.
  • Diagnosis of Alzheimer's disease according to the DSM IV
  • 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

Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil

Sham rTMS stimulation with H-coil

Device

Sham rTMS stimulation

Primary outcomes

  1. Improvement at Alzheimer's Disease Assessment Scale-cognitive over time

    Time frame: Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)

    Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Secondary outcomes

  1. Improvement at Mini Mental State Examination scale over time

    Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

    Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment

  2. Improvement at Beck Depression Inventory scale-II over time

    Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

    Self-report inventory, psychometric test used to assess the severity of depression

  3. Improvement at Clinical Global Impression-Improvement scale over time

    Time frame: Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment)

    Scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention

  4. Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time

    Time frame: Change in the score between end of treatment (2 months after start of the treatment) and end of follow-up (4 months after start of treatment)

    Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia

Sponsors and collaborators

Lead sponsor

Giancarlo Comi

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2020
Registry last updated
Sep 24, 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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