Stroke Basal GangliaKALISSNCT02884882
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia
A study testing Emotional induction in people with Stroke Basal Ganglia, run by University Hospital, Brest at 1 site in France.
Trial summary
Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Basal Ganglia
- What is being tested?
- Emotional induction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Apr 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For cases :
- right-handed patient
- ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
- Rankin score estimated prior stroke must be equal to 0 and after stroke <3 (at inclusion).
- For participants control : right-handed patient
Who cannot join
- For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of> 2 (periventricular or subcortical) - Contraindications to MRI
- For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences
Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.
- Conditions
- Stroke Basal Ganglia
- Being tested
- Emotional induction
- Keywords
- Stroke Basal Ganglia, Emotional change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional inductionOther
Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films.
| Study group | Role | What they receive |
|---|---|---|
| Emotional induction in stroke population | Other | Six films are presented, each after a relaxation period after which the basal score is measured. Receives: Other: Emotional induction |
| Emotional induction in healthy volunteers | Placebo comparator | Six films are presented, each after a relaxation period after which the basal score is measured. Receives: Other: Emotional induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The emotional experience
The emotional response will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants.
Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. Six films are presented, each after a relaxation period after which the basal score is measured.
Measured: Baseline
Secondary outcomes (1)
The recognition of facial expressions
The facial expression recognition will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants.
Percentage of recognition of facial emotions expression for each of the following 7 sizes: joy, sadness, fear, surprise, disgust, anger, no emotion; 8 frames per dimensions are presented on a total of 56 facial expressions (Ekman \& Friesen, and Karolinska series).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startDec 2011
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: difficulty to recrut
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Basal GangliaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge TIMSIT, Principal investigator, Centre Hospitalier Régional de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884882
- Sponsor's protocol ID
- KALISS RB10.077
- Acronym
- KALISS
- Status last verified
- Nov 2018
- First submitted
- 26 Aug 2016
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences
- ClinicalTrials.gov ID
- NCT02884882
- Acronym / sponsor ID
- KALISS / KALISS RB10.077
- Conditions
- Stroke Basal Ganglia
- Keywords
- Stroke Basal Ganglia, Emotional change
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty to recrut
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 31 Aug 2016 (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.
Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional induction in stroke population | Other | Other: Emotional inductionSix films are presented, each after a relaxation period after which the basal score is measured. |
| Emotional induction in healthy volunteers | Placebo comparator | Other: Emotional inductionSix films are presented, each after a relaxation period after which the basal score is measured. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For cases :
- For participants control : right-handed patient
Key exclusion criteria (2 listed)
- For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of> 2 (periventricular or subcortical) - Contraindications to MRI
- For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment
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 |
|---|---|---|
| Emotional inductionScore (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. | Other | Emotional induction in healthy volunteers, Emotional induction in stroke population |
Primary outcome
The emotional experience
Time frame: Baseline
The emotional response will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. Six films are presented, each after a relaxation period after which the basal score is measured.
1 secondary outcome
The recognition of facial expressions
Time frame: Baseline
Results and safety
The study was stopped early (reason given: difficulty to recrut). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Serge TIMSIT principal investigator
Centre Hospitalier Régional de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional induction in people with Stroke Basal Ganglia, run by University Hospital, Brest 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 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: stopped early, as of the sponsor's last update on 28 Nov 2018. 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: difficulty to recrut). 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?
The emotional experience (time frame: Baseline). 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 28 Nov 2018.