Alzheimer's DiseaseALSTIMAGNCT01481961
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Alzheimer's Disease and Cognition Disorders, run by Pierre Vandel, MD PhD at 1 site in France.
Trial summary
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Cognition Disorders
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to May 2012
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- subject under treatment by IAChE for at least 3 months.
- CDR score ≤ 2
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Who cannot join
- CDR > 2
- subjects diagnosed with psychiatric disorder (depression according to DSM-IV criteria, bipolar disorder, schizophrenia, addiction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).
This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).
Read more
Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).
The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.
- Conditions
- Alzheimer's Disease, Cognition Disorders
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Alzheimer's disease, rTMS, cognition
- Medical subject headings
- Alzheimer Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
After locating the left DLPFC, treatment with active rTMS will be directed by 20-minute session during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session). Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during rTMS for any side effects or adverse events.
| Study group | Role | What they receive |
|---|---|---|
| rTMS arm | Experimental | Not described Receives: Procedure: repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in MMSE (Mini Mental State Examination)
The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.
Measured: baseline, 1wk, 4wk
Secondary outcomes (20)
changes in HDRS (Hamilton Depression Rating Scale)
Measured: baseline, 1wk, 4wk
changes in STAI (State-Trait Anxiety Inventory)
Measured: baseline, 1wk, 4wk
changes in BDI (Beck Depression Inventory)
Measured: baseline, 1wk, 4 wk
changes in HAMA (Hamilton Anxiety Scale)
Measured: baseline, 1 wk, 4 wk
changes in Mattis DRS (Dementia Rating Scale)
Measured: baseline, 1 wk, 4 wk
changes in CDR (Clinical Dementia Rate)
Measured: baseline, 1 wk, 4 wk
changes in Grober Free and Cued Selective Reminding Test
Measured: baseline, 4 wk
changes in TMT (Trail Making Test)
Measured: baseline, 4 wk
changes in COT (Crossing Of Test)
Measured: baseline, 4 wk
changes in IST (Isaacs Set Test)
Measured: baseline, 4 wk
changes in CDT (Clock-Drawing Test)
Measured: baseline, 4 wk
changes in Signoret's Battery of Cognitive Efficacy (BEC96)
Measured: baseline, 4 wk
changes in Rey-complex figure test-copy
Measured: baseline, 4 wk
changes in Picture naming 80 items test (DO80)
Measured: baseline, 4 wk
changes in RUD (Resource Utilisation Dementia)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in AI (Apathy Inventory)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in ADL (Activities of Daily Living)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in IADL (Instrumental Activities of Daily Living)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in QoL-AD (Quality of Life in Alzheimer's Disease)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in CP6 (Questionnaire of recent change in personnality)
Measured: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionMay 2012
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's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Vandel, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J), Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E), Rapid-fr network (Dr Galmiche J), Clinical Investigation Centre for Innovative Technology Network, Funding by French Internal Project Call for Clinical Research(2010-A00659-30)
- Responsible party
- Sponsor-investigator, Pierre Vandel, MD PhD, Centre Hospitalier Universitaire de Besancon
- Investigators
- Pierre VANDEL, Prof, Principal investigator, Psychiatry clinical department - CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481961
- Sponsor's protocol ID
- ALSTIMAG
- Acronym
- ALSTIMAG
- Status last verified
- Feb 2015
- First submitted
- 23 Nov 2011
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Haffen E, Chopard G, Pretalli JB, Magnin E, Nicolier M, Monnin J, Galmiche J, Rumbach L, Pazart L, Sechter D, Vandel P. A case report of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) as an adjunctive treatment for Alzheimer disease. Brain Stimul. 2012 Jul;5(3):264-266. doi: 10.1016/j.brs.2011.03.003. Epub 2011 Mar 30. No abstract available.
PubMed 22037125
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01481961
- Acronym / sponsor ID
- ALSTIMAG / ALSTIMAG
- Conditions
- Alzheimer's Disease, Cognition Disorders
- Keywords
- Alzheimer's disease, rTMS, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pierre Vandel, MD PhDUniversity, hospital or other
- Collaborators
- Neurology department of CHU Besancon (Dr Rumbach L, Dr Berger E, Dr Galmiche J), Memory Center of Research and Resources (MCRR) of Besancon (Dr Magnin E), Rapid-fr network (Dr Galmiche J), Clinical Investigation Centre for Innovative Technology Network, Funding by French Internal Project Call for Clinical Research(2010-A00659-30)
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Nov 2011 (estimated)
- 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.
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).
This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).
Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).
The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS arm | Experimental | Procedure: repetitive Transcranial Magnetic Stimulation (rTMS) |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- subject under treatment by IAChE for at least 3 months.
- CDR score ≤ 2
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Key exclusion criteria (2 listed)
- CDR > 2
- subjects diagnosed with psychiatric disorder (depression according to DSM-IV criteria, bipolar disorder, schizophrenia, addiction)
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 |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS)After locating the left DLPFC, treatment with active rTMS will be directed by 20-minute session during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session). Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during rTMS for any side effects or adverse events. | Procedure or surgery | rTMS arm |
Primary outcome
changes in MMSE (Mini Mental State Examination)
Time frame: baseline, 1wk, 4wk
The changes in MMSE will constitute the major research outcome measure used to assess response to rTMS.
20 secondary outcomes
changes in HDRS (Hamilton Depression Rating Scale)
Time frame: baseline, 1wk, 4wk
changes in STAI (State-Trait Anxiety Inventory)
Time frame: baseline, 1wk, 4wk
changes in BDI (Beck Depression Inventory)
Time frame: baseline, 1wk, 4 wk
changes in HAMA (Hamilton Anxiety Scale)
Time frame: baseline, 1 wk, 4 wk
changes in Mattis DRS (Dementia Rating Scale)
Time frame: baseline, 1 wk, 4 wk
changes in CDR (Clinical Dementia Rate)
Time frame: baseline, 1 wk, 4 wk
changes in Grober Free and Cued Selective Reminding Test
Time frame: baseline, 4 wk
changes in TMT (Trail Making Test)
Time frame: baseline, 4 wk
changes in COT (Crossing Of Test)
Time frame: baseline, 4 wk
changes in IST (Isaacs Set Test)
Time frame: baseline, 4 wk
changes in CDT (Clock-Drawing Test)
Time frame: baseline, 4 wk
changes in Signoret's Battery of Cognitive Efficacy (BEC96)
Time frame: baseline, 4 wk
changes in Rey-complex figure test-copy
Time frame: baseline, 4 wk
changes in Picture naming 80 items test (DO80)
Time frame: baseline, 4 wk
changes in RUD (Resource Utilisation Dementia)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in AI (Apathy Inventory)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in ADL (Activities of Daily Living)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in IADL (Instrumental Activities of Daily Living)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in QoL-AD (Quality of Life in Alzheimer's Disease)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
changes in CP6 (Questionnaire of recent change in personnality)
Time frame: baseline, at the end of treatment, 1wk, 2 wk, 3 wk, 4 wk
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 3 Mar 2015.
- Results publication: PubMed 22037125Haffen E, Chopard G, Pretalli JB, Magnin E, Nicolier M, Monnin J, Galmiche J, Rumbach L, Pazart L, Sechter D, Vandel P. A case report of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) as an adjunctive treatment for Alzheimer disease. Brain Stimul. 2012 Jul;5(3):264-266. doi: 10.1016/j.brs.2011.03.003. Epub 2011 Mar 30. No abstract available.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Pierre VANDEL, Prof principal investigator
Psychiatry clinical department - CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) in people with Alzheimer's Disease and Cognition Disorders, run by Pierre Vandel, MD PhD at 1 site in France.
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 4 inclusion and 2 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 3 Mar 2015. 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 France. 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. 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?
changes in MMSE (Mini Mental State Examination) (time frame: baseline, 1wk, 4wk). 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 NCT01481961, 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 3 Mar 2015.