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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562506
• Other study ID #: rTMS-AD
• Status: Completed
• Phase: N/A
• Start date: October 21, 2010
• Est. completion date: September 8, 2014

Study information

• Verified date: September 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 8, 2014
• Est. primary completion date: September 8, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• rTMS with H-coil
Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil
• Sham rTMS stimulation with H-coil
Sham rTMS stimulation

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	Improvement at Alzheimer's Disease Assessment Scale-cognitive over time	Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia	Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)
Secondary	Improvement at Mini Mental State Examination scale over time	Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment	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)
Secondary	Improvement at Beck Depression Inventory scale-II over time	Self-report inventory, psychometric test used to assess the severity of depression	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)
Secondary	Improvement at Clinical Global Impression-Improvement scale over time	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	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)
Secondary	Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time	Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia	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)