A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

HIV Clinical Trial

— HtDCS  

Official title:

Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391311
• Other study ID #: K99AG048762
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: May 12, 2017
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• HIV

Intervention

Device:
• transcranial direct current stimulation (tDCS)
tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.

Locations

Country	Name	City	State
United States	UAB 1917 Clinic	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Processing of Speed	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.	baseline, 6 week posttest
Secondary	Change in Driving Simulator Performance	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.	baseline, 6 week posttest