CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy

Not Applicable

• Conditions: HIV
• Interventions: Other: neuropsychological tests; Other: STAI-Y scale for anxiety; Other: Beck scale for depression; Other: without intervention

• Registration Number: NCT02343887
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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. 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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23
• Primary Completion: 2017-01
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• • 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)
• 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)

Exclusion Criteria

• 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
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	neuropsychological tests	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).
control group	without intervention	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).
group with cognitive rehabilitation,	STAI-Y scale for anxiety	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).
group with psychological support.	neuropsychological tests	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).
control group	STAI-Y scale for anxiety	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).
control group	Beck scale for depression	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).
group with psychological support.	Beck scale for depression	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).
group with cognitive rehabilitation,	neuropsychological tests	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).
group with cognitive rehabilitation,	Beck scale for depression	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).
group with psychological support.	STAI-Y scale for anxiety	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).

Primary Outcome Measures

Name	Time	Method
cognitive remediation strategy (BREF test)	6 months	- BREF test
cognitive remediation strategy (RLRI-16 test6.)	6 months	- RLRI-16 test6.
cognitive remediation strategy (Digit Symbol Substitution Test)	6 months	- Digit Symbol Substitution Test
cognitive remediation strategy (grooved pegboard test)	6 months	- grooved pegboard test

Secondary Outcome Measures

Name	Time	Method
impact on daily life quality (Trail Making Test)	6 months	-Trail Making Test
impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)	6 months	SF-12 Medical Outcomes Study Short-Form General Health Survey"

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, Paca, France