HealthyNCT01861639
Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.
A study testing ineffective rTMS, active TBS and fMRI in people with Healthy, run by Qualissima at 2 sites in 2 countries.
Trial summary
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ineffective rTMS, active TBS and fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2013to Dec 2015
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged between 18 and 40 years-old inclusive.
- Education level: at least secondary.
- Right-handed (Edinburgh Handedness Inventory).
- The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
- No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
- No history of neurological disorders
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- No history of concussion (cranial or facial trauma) without or with loss of consciousness.
- Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor...).
- Subject without lesion on MRI.
- Subject without abnormal electrical activities on standard clinical EEG.
- No history of drug or alcohol abuse.
- No smoker or ≤ 5 cg/ day.
- The subject can complete the neuropsychological test battery during the training session.
- Subject without contraindication to MRI.
- The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions.
- The subject is covered by a social insurance.
- The subject has provided written informed consent.
Who cannot join
- History or presence of psychiatric illness (Psychiatric interview).
- History or presence of neurologic illness.
- The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
- The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
- Presence of metallic objects within the body.
- Subjects with pacemaker.
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- Claustrophobia.
- Individual and familial history of epileptic seizure.
- Any medication listed (see annexe) in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
- Subject with a correct hit rate during the retrieval session of the memory task
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).
Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.
- Conditions
- Healthy
- Being tested
- ineffective rTMS, active TBS, Sham TBS, fMRI, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ineffective rTMSDevice
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
active TBSDevice
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Sham TBSDevice
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
fMRIDevice
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
EEGDevice
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
Effective rTMSDevice
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
| Study group | Role | What they receive |
|---|---|---|
| ineffective rTMS - Active TBS - fMRI | Experimental | Not described Receives: Device: ineffective rTMS; Device: active TBS; Device: fMRI |
| Effective rTMS - Active TBS - fMRI | Experimental | Not described Receives: Device: active TBS; Device: fMRI; Device: Effective rTMS |
| ineffective rTMS - Sham TBS - fMRI | Sham comparator | Not described Receives: Device: ineffective rTMS; Device: Sham TBS; Device: fMRI |
| Effective rTMS - Sham TBS - fMRI | Sham comparator | Not described Receives: Device: Sham TBS; Device: fMRI; Device: Effective rTMS |
| ineffective rTMS - Active TBS - EEG | Experimental | Not described Receives: Device: ineffective rTMS; Device: active TBS; Device: EEG |
| Effective rTMS - Active TBS - EEG | Experimental | Not described Receives: Device: active TBS; Device: EEG; Device: Effective rTMS |
| ineffective rTMS - Sham TBS - EEG | Sham comparator | Not described Receives: Device: ineffective rTMS; Device: Sham TBS; Device: EEG |
| Effective rTMS - Sham TBS - EEG | Sham comparator | Not described Receives: Device: Sham TBS; Device: EEG; Device: Effective rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outputs of the memory task
outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).
Measured: up to Day 15
Secondary outcomes (3)
CANTAB task
- CANTAB / Rapid Visual Information Processing (RVIP)
- CANTAB / Spatial Working Memory (SWM)
- CANTAB / Paired Associates Learning (PAL)
Measured: Day 1 and Day 15
Gene expression
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
Measured: Day 1
Imaging
Functional MRI (Barcelona): modifications will be highlighted by changes in Blood Oxydation level Dependence (BOLD)signal patterns
EEG (Marseille): modifications will be highlighted by changes in EEG markers
Measured: Day1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Timeframe of the IMI project couldn't be expended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qualissima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bartrés-Faz, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i SunyerChristine Audebert, Principal investigator, CIC-CPCET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861639
- Sponsor's protocol ID
- WP1P003
- Status last verified
- Apr 2016
- First submitted
- 16 May 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart
- ClinicalTrials.gov ID
- NCT01861639
- Acronym / sponsor ID
- WP1P003
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Timeframe of the IMI project couldn't be expended
- Enrolment
- 158 participants (actual)
- Lead sponsor
- QualissimaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2013 (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.
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).
Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ineffective rTMS - Active TBS - fMRI | Experimental | Device: ineffective rTMS, Device: active TBS, Device: fMRI |
| Effective rTMS - Active TBS - fMRI | Experimental | Device: active TBS, Device: fMRI, Device: Effective rTMS |
| ineffective rTMS - Sham TBS - fMRI | Sham comparator | Device: ineffective rTMS, Device: Sham TBS, Device: fMRI |
| Effective rTMS - Sham TBS - fMRI | Sham comparator | Device: Sham TBS, Device: fMRI, Device: Effective rTMS |
| ineffective rTMS - Active TBS - EEG | Experimental | Device: ineffective rTMS, Device: active TBS, Device: EEG |
| Effective rTMS - Active TBS - EEG | Experimental | Device: active TBS, Device: EEG, Device: Effective rTMS |
| ineffective rTMS - Sham TBS - EEG | Sham comparator | Device: ineffective rTMS, Device: Sham TBS, Device: EEG |
| Effective rTMS - Sham TBS - EEG | Sham comparator | Device: Sham TBS, Device: EEG, Device: Effective rTMS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male subjects aged between 18 and 40 years-old inclusive.
- Education level: at least secondary.
- Right-handed (Edinburgh Handedness Inventory).
- The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
- No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
Key exclusion criteria (10 listed)
- History or presence of psychiatric illness (Psychiatric interview).
- History or presence of neurologic illness.
- The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
- The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
- Presence of metallic objects within the body.
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 |
|---|---|---|
| ineffective rTMSA 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation. | Device | ineffective rTMS - Active TBS - EEG, ineffective rTMS - Active TBS - fMRI, ineffective rTMS - Sham TBS - EEG, ineffective rTMS - Sham TBS - fMRI |
| active TBSA continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec | Device | Effective rTMS - Active TBS - EEG, Effective rTMS - Active TBS - fMRI, ineffective rTMS - Active TBS - EEG, ineffective rTMS - Active TBS - fMRI |
| Sham TBSA Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used. | Device | Effective rTMS - Sham TBS - EEG, Effective rTMS - Sham TBS - fMRI, ineffective rTMS - Sham TBS - EEG, ineffective rTMS - Sham TBS - fMRI |
| fMRIFunctional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence | Device | Effective rTMS - Active TBS - fMRI, Effective rTMS - Sham TBS - fMRI, ineffective rTMS - Active TBS - fMRI, ineffective rTMS - Sham TBS - fMRI |
| EEGEEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task. | Device | Effective rTMS - Active TBS - EEG, Effective rTMS - Sham TBS - EEG, ineffective rTMS - Active TBS - EEG, ineffective rTMS - Sham TBS - EEG |
| Effective rTMSA 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation. | Device | Effective rTMS - Active TBS - EEG, Effective rTMS - Active TBS - fMRI, Effective rTMS - Sham TBS - EEG, Effective rTMS - Sham TBS - fMRI |
Primary outcome
Outputs of the memory task
Time frame: up to Day 15
outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).
3 secondary outcomes
CANTAB task
Time frame: Day 1 and Day 15
Gene expression
Time frame: Day 1
Imaging
Time frame: Day1 and Day 15
Results and safety
The study was stopped early (reason given: Timeframe of the IMI project couldn't be expended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
David Bartrés-Faz principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Christine Audebert principal investigator
CIC-CPCET
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ineffective rTMS, active TBS and fMRI in people with Healthy, run by Qualissima at 2 sites in 2 countries.
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 17 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. 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 was stopped early (reason given: Timeframe of the IMI project couldn't be expended). Results are not available in the source record.
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?
Outputs of the memory task (time frame: up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2016.