HIVCogStimNCT02343887
CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy
A study testing neuropsychological tests, STAI-Y scale for anxiety and Beck scale for depression in people with HIV, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV
- What is being tested?
- neuropsychological tests, STAI-Y scale for anxiety and Beck scale for depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Oct 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Seropositive for HIV-1 Patient
- With a plasma viral load below the limit of detection for minimum 6 months (HIV viral load <40 copies / ml)
- On stable antiretroviral therapy for 12 months, according to the revised optimized subject to the constraints of genotypic resistance and CPE score in the absence of cons-indication to treatment intensive brain penetration (Annex 15)
- With cognitive complaint objectified by the cognitive complaint questionnaire (Appendix 9: score 3 or 1 positive response among the items C4, C5, C7, C8) and cognitive impairment found by an alteration of at least two cognitive fields assessed by psychometric tests for at least 6 months
- 18 <age <55 years
- No defined by a marked depression scale score of Beck <16 (Appendix 13)
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- No marked anxiety defined by a T score> 55 on the scale of Spielberger STAI-Y (Annex 14)
- Insured under the social security
- Who signed the consent form.
- Recent brain imaging excluding other causes of cognitive impairment (MRI or CT brain injected injected so-indication against MRI)
Who cannot join
- A patient diagnosed and followed for more than six months psychiatric disorder that could interfere with psychometric assessment
- Patients with a poor understanding of French,
- Patients with active opportunistic infection of the CNS or with neurological sequelae.
- History of head trauma
- Active Substance excluding cannabis
- Patient for which a change of antiretroviral therapy is provided within 12 months
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- Patient for which interferon treatment is provided within 12 months
- Patient placed under guardianship,
- Patient with HIV-related dementia
- Liver cirrhosis Child B or C (Annex 16)
- Severe renal impairment (creatinine clearance by Cockcroft <30 ml / min)
Trial locations and contacts
1 site in 1 country.
Olivia ZAEGEL- FAUCHER contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, Paca, 13354
olivia zaegel, olivia.zaegel@ap-hm.fr
About this study
Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. To this day, no therapy tested has proved its efficiency, including the strategy of the antiretroviral therapy (cART) optimization according to the Cerebral Penetration effectiveness Score (CPE).
Description of the study: an open prospective comparative monocentric pilote study, randomised in three groups which investigates the efficiency of a 6 months-cognitive rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV infection. Those who have severe psychiatric disorder or who are on medication that could interfere with psychometrical tests will be excluded.
Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months period on the evolution of minor cognitive disorders and asymptomatic patients to a control group and a group treated with psychological support.
Read the detailed description
This is an open prospective comparative monocentric study, pilote, that randomised 60 patients in three groups of 20. This study will select 18 to 55 years old patients, with HIV infection controlled under antiretroviral therapy stble for 12 months and cognitive impairment objective on two neuropsychological evaluations separated from 6 months at least. All selected patients must have been explored by cerebral RMN or scanner
- Conditions
- HIV
- Being tested
- neuropsychological tests, STAI-Y scale for anxiety, Beck scale for depression, without intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testsOther
STAI-Y scale for anxietyOther
Beck scale for depressionOther
without interventionOther
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | patients without taking into cognitive or psychological treatment for 6 months (period 1) and
* if the situation improves in the neuropsychological assessment of M6 further with simple monitoring neuropsychological evaluation M12
* or persistence or worsening of the disorder, the beginning of a cognitive remediation program for 6 months (period 2). Receives: Other: neuropsychological tests; Other: STAI-Y scale for anxiety; Other: Beck scale for depression; Other: without intervention |
| group with cognitive rehabilitation, | Experimental | patients treated for 6 months Cognitive remediation (period 1), then
* Stop if the situation improves in the evaluation and monitoring of M6 to M12 with neuropsychological assessment,
* or persistence or worsening of the disorder, further cognitive remediation for 6 months (period 2). Receives: Other: neuropsychological tests; Other: STAI-Y scale for anxiety; Other: Beck scale for depression |
| group with psychological support. | Experimental | patients treated with counseling for six months (period 1) and
* Stop if the situation improves with neuropsychological assessment and monitoring to M12,
* or if persistent or worsening unrest in the neuropsychological assessment of M6, the beginning of a cognitive remediation program for 6 months (period 2). Receives: Other: neuropsychological tests; Other: STAI-Y scale for anxiety; Other: Beck scale for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive remediation strategy (BREF test)
- BREF test
Measured: 6 months
cognitive remediation strategy (grooved pegboard test)
- grooved pegboard test
Measured: 6 months
cognitive remediation strategy (RLRI-16 test6.)
- RLRI-16 test6.
Measured: 6 months
cognitive remediation strategy (Digit Symbol Substitution Test)
- Digit Symbol Substitution Test
Measured: 6 months
Secondary outcomes (2)
impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)
SF-12 Medical Outcomes Study Short-Form General Health Survey"
Measured: 6 months
impact on daily life quality (Trail Making Test)
-Trail Making Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343887
- Sponsor's protocol ID
- 2013-49
- Other IDs
- 2013-A01621-44
- Acronym
- CogStim
- Status last verified
- Oct 2015
- First submitted
- 14 Nov 2014
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02343887
- Acronym / sponsor ID
- CogStim / 2013-49
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 22 Jan 2015 (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.
Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. To this day, no therapy tested has proved its efficiency, including the strategy of the antiretroviral therapy (cART) optimization according to the Cerebral Penetration effectiveness Score (CPE).
Description of the study: an open prospective comparative monocentric pilote study, randomised in three groups which investigates the efficiency of a 6 months-cognitive rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV infection. Those who have severe psychiatric disorder or who are on medication that could interfere with psychometrical tests will be excluded.
Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months period on the evolution of minor cognitive disorders and asymptomatic patients to a control group and a group treated with psychological support.
Detailed description
This is an open prospective comparative monocentric study, pilote, that randomised 60 patients in three groups of 20. This study will select 18 to 55 years old patients, with HIV infection controlled under antiretroviral therapy stble for 12 months and cognitive impairment objective on two neuropsychological evaluations separated from 6 months at least. All selected patients must have been explored by cerebral RMN or scanner
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: neuropsychological tests, Other: STAI-Y scale for anxiety, Other: Beck scale for depression, Other: without interventionpatients without taking into cognitive or psychological treatment for 6 months (period 1) and * if the situation improves in the neuropsychological assessment of M6 further with simple monitoring neuropsychological evaluation M12 * or persistence or worsening of the disorder, the beginning of a cognitive remediation program for 6 months (period 2). |
| group with cognitive rehabilitation, | Experimental | Other: neuropsychological tests, Other: STAI-Y scale for anxiety, Other: Beck scale for depressionpatients treated for 6 months Cognitive remediation (period 1), then * Stop if the situation improves in the evaluation and monitoring of M6 to M12 with neuropsychological assessment, * or persistence or worsening of the disorder, further cognitive remediation for 6 months (period 2). |
| group with psychological support. | Experimental | Other: neuropsychological tests, Other: STAI-Y scale for anxiety, Other: Beck scale for depressionpatients treated with counseling for six months (period 1) and * Stop if the situation improves with neuropsychological assessment and monitoring to M12, * or if persistent or worsening unrest in the neuropsychological assessment of M6, the beginning of a cognitive remediation program for 6 months (period 2). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- - Seropositive for HIV-1 Patient
- With a plasma viral load below the limit of detection for minimum 6 months (HIV viral load <40 copies / ml)
- On stable antiretroviral therapy for 12 months, according to the revised optimized subject to the constraints of genotypic resistance and CPE score in the absence of cons-indication to treatment intensive brain penetration (Annex 15)
- With cognitive complaint objectified by the cognitive complaint questionnaire (Appendix 9: score 3 or 1 positive response among the items C4, C5, C7, C8) and cognitive impairment found by an alteration of at least two cognitive fields assessed by psychometric tests for at least 6 months
- 18 <age <55 years
Key exclusion criteria (11 listed)
- A patient diagnosed and followed for more than six months psychiatric disorder that could interfere with psychometric assessment
- Patients with a poor understanding of French,
- Patients with active opportunistic infection of the CNS or with neurological sequelae.
- History of head trauma
- Active Substance excluding cannabis
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 |
|---|---|---|
| neuropsychological tests | Other | control group, group with cognitive rehabilitation,, group with psychological support. |
| STAI-Y scale for anxiety | Other | control group, group with cognitive rehabilitation,, group with psychological support. |
| Beck scale for depression | Other | control group, group with cognitive rehabilitation,, group with psychological support. |
| without intervention | Other | control group |
Primary outcome
cognitive remediation strategy (BREF test)
Time frame: 6 months
- BREF test
cognitive remediation strategy (grooved pegboard test)
Time frame: 6 months
- grooved pegboard test
cognitive remediation strategy (RLRI-16 test6.)
Time frame: 6 months
- RLRI-16 test6.
cognitive remediation strategy (Digit Symbol Substitution Test)
Time frame: 6 months
- Digit Symbol Substitution Test
2 secondary outcomes
impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)
Time frame: 6 months
impact on daily life quality (Trail Making Test)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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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.
Olivia ZAEGEL- FAUCHER contact
Urielle DESALBRES study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological tests, STAI-Y scale for anxiety and Beck scale for depression in people with HIV, run by Assistance Publique Hopitaux De Marseille 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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivia ZAEGEL- FAUCHER (olivia.zaegel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive remediation strategy (BREF test) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 23 Oct 2015.