A Phase 1 interventional study of Smartbrain in HIV Infections, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by University of Pittsburgh · Phase 1, Interventional, and Treatment
There has been little success in treating the cognitive (thinking) problems associated with HIV/AIDS using medications. The purpose of this study is to determine whether an internet-based cognitive "stimulation" program might help HIV-infected individuals think more clearly. If this is true, then it means that people with mild forms of cognitive impairment may be able to help themselves to get better.
The neurocognitive manifestations of HIV/AIDS have long been recognized as important for the management, survival, and quality of life of affected patients and their families. Following the advent of Highly active anti-retroviral therapy (HAART) the incidence of HIV-associated dementia (HAD) has fallen, but the prevalence of the milder forms of HIV-related cognitive disorders has risen. This is important because alterations in cognitive function can have significant impact on work and social activities, mood, and perceived quality of life. To date, pharmacological management of HIV-associated cognitive disorders - apart from HAART - have met with limited success (e.g., Peptide T, Ritalin). Therefore, it appears reasonable to ask whether the use of non-pharmacological tools might help alleviate or ameliorate the symptoms of the milder forms of cognitive impairment, and thus improve mood and activities of daily living. The purpose of this application is to request funds to allow us to complete a feasibility/pilot study of the merits of using an internet-based cognitive stimulation program (CSP) to improve the cognitive functions and quality of life of individuals with HIV/AIDS, and, secondarily, to detect such changes using a computerized assessment tool designed for use in a health care practitioner's office (Computer-Based Assessment of Mild Cognitive Impairment (CAMCI)).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Crieria:
Subjects will be given Internet access to the Smartbrain cognitive stimulation program. They will complete exercises for \~30 minutes, at least three times per week, for a period of 24 weeks.
Behavioral: Smartbrain
These individuals will receive "usual care" during the 24 week follow-up period.
The initial session will be set for 10 minutes, with weekly increases (of 10 minutes) to a maximum of 30 minutes per day, 7 days a week. Each subject will be trained using the same modules of the Smartbrain protocol, with an emphasis on speed of information processing.
Also known as: Cognitive stimulation
Global Impairment Rating from battery of neuropsychological tests.
Time frame: 24 weeks
Change in perceived quality of life using MOS/HIV
Time frame: 24 weeks
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh