A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

Not Applicable

Completed

• Conditions: HIV; Aging

• Registration Number: NCT02391311
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-03-17
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• HIV+
• Aged 50 and older
• Patient at University HIV/AIDS Clinic

Exclusion Criteria

• Not homeless
• Not blind or deaf
• No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures)
• No pacemaker or other biomedical devices or metal implants
• No untreated hypertension
• Not undergoing chemo or radiation
• No head injury with LOC greater than 30 mins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Processing of Speed	baseline, 6 week posttest	Computerized and paper \& pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.

Secondary Outcome Measures

Name	Time	Method
Change in Driving Simulator Performance	baseline, 6 week posttest	Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.

Trial Locations

Locations (1)

UAB 1917 Clinic; 🇺🇸 Birmingham, Alabama, United States