N/A
N=42
A Novel Neurorehabilitation Approach for Cognitive Aging With HIV
HIV · Aging
Bottom Line
View on ClinicalTrials.gov: NCT02391311 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in the Processing of Speed — 2.63; 6.06 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Processing of Speed |
2.63; 6.06 | — |
| SECONDARY Change in Driving Simulator Performance |
1.867; -1.800 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02391311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.