- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562506
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease
September 23, 2020 updated by: Giancarlo Comi
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease: A Double-blind, Placebo-controlled Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MI
-
Milan, MI, Italy, 20132
- Irccs San Raffaele
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Real rTMS stimulation
real deep excitatory, high frequency rTMS with H-coil stimulation
|
Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil
|
Sham Comparator: Sham rTMS stimulation
sham high frequency H-coil stimulation
|
Sham rTMS stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
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
|
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)
|
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
|
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)
|
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
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giancarlo Comi, MD, Irccs San Raffaele
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 21, 2010
Primary Completion (Actual)
September 8, 2014
Study Completion (Actual)
September 8, 2014
Study Registration Dates
First Submitted
September 18, 2020
First Submitted That Met QC Criteria
September 23, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 24, 2020
Last Update Submitted That Met QC Criteria
September 23, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rTMS-AD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
IPD Sharing Supporting Information Type
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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