Alzheimer DiseaseNCT04562506
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease
A study testing rTMS with H-coil in people with Alzheimer Disease, run by Giancarlo Comi at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- rTMS with H-coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2010to 8 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS
- Conditions
- Alzheimer Disease
- Being tested
- rTMS with H-coil, Sham rTMS stimulation with H-coil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS with H-coilDevice
Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil
Sham rTMS stimulation with H-coilDevice
Sham rTMS stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS stimulation | Active comparator | real deep excitatory, high frequency rTMS with H-coil stimulation Receives: Device: rTMS with H-coil |
| Sham rTMS stimulation | Sham comparator | sham high frequency H-coil stimulation Receives: Device: Sham rTMS stimulation with H-coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement at Alzheimer's Disease Assessment Scale-cognitive over time
Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia
Measured: Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)
Secondary outcomes (4)
Improvement at Mini Mental State Examination scale over time
Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment
Measured: 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
Self-report inventory, psychometric test used to assess the severity of depression
Measured: 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
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
Measured: 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
Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 Oct 2010
- Primary completion8 Sep 2014
- Study completion8 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giancarlo Comi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giancarlo Comi, IRCCS San Raffaele
- Investigators
- Giancarlo Comi, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562506
- Sponsor's protocol ID
- rTMS-AD
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Leocani L, Dalla Costa G, Coppi E, Santangelo R, Pisa M, Ferrari L, Bernasconi MP, Falautano M, Zangen A, Magnani G, Comi G. Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study. Front Neurol. 2021 Feb 18;11:614351. doi: 10.3389/fneur.2020.614351. eCollection 2020.
PubMed 33679572
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease: A Double-blind, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04562506
- Acronym / sponsor ID
- rTMS-AD
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Giancarlo ComiUniversity, hospital or other
- Study start
- 21 Oct 2010 (actual)
- Primary completion
- 8 Sep 2014 (actual)
- Study completion
- 8 Sep 2014 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS stimulation | Active comparator | Device: rTMS with H-coilreal deep excitatory, high frequency rTMS with H-coil stimulation |
| Sham rTMS stimulation | Sham comparator | Device: Sham rTMS stimulation with H-coilsham high frequency H-coil stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS with H-coilDeep repetitive transcranial manetic stimulation or sham stimulation with H-coil | Device | Real rTMS stimulation |
| Sham rTMS stimulation with H-coilSham rTMS stimulation | Device | Sham rTMS stimulation |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Derived from this study: PubMed 33679572Leocani L, Dalla Costa G, Coppi E, Santangelo R, Pisa M, Ferrari L, Bernasconi MP, Falautano M, Zangen A, Magnani G, Comi G. Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study. Front Neurol. 2021 Feb 18;11:614351. doi: 10.3389/fneur.2020.614351. eCollection 2020.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Comi, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS with H-coil in people with Alzheimer Disease, run by Giancarlo Comi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.