Cerebral InfarctionEFLUSTIMNCT02063425
"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"
A study testing Fluoxetine in people with Cerebral Infarction, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man and women, aged from 18 to 80 years.
- Social security affiliation
- Inclusion from day 3 to day 15 after stroke or brain haemorrhage
- Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10)
- Informed consent
Who cannot join
- Score NIHSS > 20
- Depression (criteria DSM5-R) with MADRS score > 19
- History of recurrent bipolar or depressive disorders.
- History of behavior or suicidal idea
- Family history of extension of the interval QT or congenital long interval QT
- History of clinical stroke
Show all 17Show fewer
- Aphasia preventing correct evaluation of motor and depression scales.
- Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
- Benzodiazepines within 48 hours preceding inclusion.
- Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill)
- Severe swallowing disorders preventing oral administration of the treatment
- Planned carotid surgery
- Pregnant or breast-feeding woman
- Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l)
- Concomitant severe disease not allowing follow-up.
- Participation to another therapeutic study.
- Contraindication to MRI and TMS
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.
Read the detailed description
Recently, a phase IIb clinical trial (Chollet et al., 2011 - FLAME study) revealed that early administration of standard-dose oral fluoxetine (a selective serotonin re-uptake inhibitor widely used as antidepressant) to patients with subacute ischaemic stroke and moderate to severe motor deficit in the upper extremity enhanced motor recovery after 3 months, as assessed by the Fugl-Meyer motor scale, suggesting that fluoxetine could be a promising drug to promote recovery in stroke patients. However, the mechanisms, and their specificity, by which fluoxetine improves motor function after stroke remain poorly understood.
The overall objective of this proposal is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
The corticospinal system plays a key role in voluntary activation of upper limb muscles. Its integrity has been related to spontaneous (but incomplete) recovery after stroke. So far, the effect of fluoxetine on corticospinal excitability and integrity has been poorly explored although this drug appears promising to promote motor recovery.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity. The investigators believe that this approach will be suitable to determine the mechanisms of action of this drug on motor recovery after stroke.
The investigators will assess in a double-blind, monocentric (Saint-Anne Hospital Stroke center), randomised, placebo-controlled study, the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity using TMS in 40 patients suffering from ischaemic stroke with hemiplegia or hemiparesis affecting motor hand functions.
By coupling TMS, visuomotor grip tracking task and several clinical scales, the investigators' results will allow a more system-specific assessment than the Fugl-Meyer motor scale of fluoxetine-induced motor hand recovery in stroke. We believe that this study will support the beneficial effect of fluoxetine to promote motor recovery in stroke and will open new vistas for treatment options using fluoxetine in patients with motor impairments. It is expected that this study will provide preliminary data that will be subsequently used to design new, more focused, clinical trials.
- Conditions
- Cerebral Infarction
- Being tested
- Fluoxetine, Placebo of fluoxetine
- Keywords
- Motor recovery, Fluoxetine, Transcranial magnetic stimulation, stroke
- Medical subject headings
- Cerebral Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Patients receiving fluoxetine
1 pill of 20mg / day, during 3 months
Placebo of fluoxetineDrug
Also called Patients receiving placebo
1 pill of 20mg/day, during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Active comparator | Not described Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of the curve of recruitment of the PEMs
Significant difference, between the treated group and the group control, of the slope of the curve of recruitment of the PEMs between the beginning (D0) and the end of the treatment (processing) (M3).
Measured: M3
Secondary outcomes (4)
Slope of recruitment of the PEMs
Effect of a first dose of fluoxétine on the slope of recruitment of the PEMs.
Measured: D0, M3, M6
Slope of recruitment of the PEMs
Persistence of fluoxétine effect on the slope of recruitment of the PEMs to M6.
Measured: D0, M3, M6
Index finger force control in paretic hand under time-course of treatment of Fluoxetine
A visuomotor tracking task is used to measure accuracy of force control (NewtonSecond, Ns) and time taken to release force (release duration, ms). Performance between time-points will be measured (Ns, before-after treatment).
Effects of fluoxetine on force control parameters (e.g., accuracy and release duration) in paretic hand.
Measured: D0, M3, M6
in index finger force control in non-paretic hand under time-course of treatment of Fluoxetine
Same visuomotor tracking mesures as above but acquired in non-paretic hand. Effects of fluoxetine on the non-affected hand (error, Ns; release duration, ms).
Measured: D0, M3, M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Not enough recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude BARON, MD, Study director, Centre Hospitalier Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063425
- Sponsor's protocol ID
- D505
- Other IDs
- 2013-001313-32
- Acronym
- EFLUSTIM
- Status last verified
- Oct 2017
- First submitted
- 6 Jan 2014
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"
- ClinicalTrials.gov ID
- NCT02063425
- Acronym / sponsor ID
- EFLUSTIM / D505
- Conditions
- Cerebral Infarction
- Keywords
- Motor recovery, Fluoxetine, Transcranial magnetic stimulation, stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Feb 2014 (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 objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.
Detailed description
Recently, a phase IIb clinical trial (Chollet et al., 2011 - FLAME study) revealed that early administration of standard-dose oral fluoxetine (a selective serotonin re-uptake inhibitor widely used as antidepressant) to patients with subacute ischaemic stroke and moderate to severe motor deficit in the upper extremity enhanced motor recovery after 3 months, as assessed by the Fugl-Meyer motor scale, suggesting that fluoxetine could be a promising drug to promote recovery in stroke patients. However, the mechanisms, and their specificity, by which fluoxetine improves motor function after stroke remain poorly understood.
The overall objective of this proposal is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
The corticospinal system plays a key role in voluntary activation of upper limb muscles. Its integrity has been related to spontaneous (but incomplete) recovery after stroke. So far, the effect of fluoxetine on corticospinal excitability and integrity has been poorly explored although this drug appears promising to promote motor recovery.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity. The investigators believe that this approach will be suitable to determine the mechanisms of action of this drug on motor recovery after stroke.
The investigators will assess in a double-blind, monocentric (Saint-Anne Hospital Stroke center), randomised, placebo-controlled study, the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity using TMS in 40 patients suffering from ischaemic stroke with hemiplegia or hemiparesis affecting motor hand functions.
By coupling TMS, visuomotor grip tracking task and several clinical scales, the investigators' results will allow a more system-specific assessment than the Fugl-Meyer motor scale of fluoxetine-induced motor hand recovery in stroke. We believe that this study will support the beneficial effect of fluoxetine to promote motor recovery in stroke and will open new vistas for treatment options using fluoxetine in patients with motor impairments. It is expected that this study will provide preliminary data that will be subsequently used to design new, more focused, clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Active comparator | Drug: Fluoxetine |
| Placebo | Placebo comparator | Drug: Placebo of fluoxetine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man and women, aged from 18 to 80 years.
- Social security affiliation
- Inclusion from day 3 to day 15 after stroke or brain haemorrhage
- Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10)
- Informed consent
Key exclusion criteria (17 listed)
- Score NIHSS > 20
- Depression (criteria DSM5-R) with MADRS score > 19
- History of recurrent bipolar or depressive disorders.
- History of behavior or suicidal idea
- Family history of extension of the interval QT or congenital long interval QT
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 |
|---|---|---|
| FluoxetineAlso: Patients receiving fluoxetine1 pill of 20mg / day, during 3 months | Drug | Fluoxetine |
| Placebo of fluoxetineAlso: Patients receiving placebo1 pill of 20mg/day, during 3 months | Drug | Placebo |
Primary outcome
Slope of the curve of recruitment of the PEMs
Time frame: M3
Significant difference, between the treated group and the group control, of the slope of the curve of recruitment of the PEMs between the beginning (D0) and the end of the treatment (processing) (M3).
4 secondary outcomes
Slope of recruitment of the PEMs
Time frame: D0, M3, M6
Slope of recruitment of the PEMs
Time frame: D0, M3, M6
Index finger force control in paretic hand under time-course of treatment of Fluoxetine
Time frame: D0, M3, M6
in index finger force control in non-paretic hand under time-course of treatment of Fluoxetine
Time frame: D0, M3, M6
Results and safety
The study was stopped early (reason given: Not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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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.
Jean-Claude BARON, MD study director
Centre Hospitalier Sainte-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Cerebral Infarction, run by Centre Hospitalier St Anne 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 5 inclusion and 17 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 20 Oct 2017. 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. 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: Not enough recruitment). 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?
Slope of the curve of recruitment of the PEMs (time frame: M3). 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 20 Oct 2017.