A Novel Neurorehabilitation Approach for Cognitive Aging With HIV (HtDCS)

• ClinicalTrials.gov Identifier: NCT02391311
• Recruitment Status: Completed
• First Posted: March 18, 2015
• Results First Posted: May 15, 2017
• Last Update Posted: May 15, 2017
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Pariya L. Fazeli, PhD, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV; Aging	Device: transcranial direct current stimulation (tDCS)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)
• Study Start Date: March 2015
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sham tDCS + Cognitive Remediation; Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.	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.; Other Name: transcranial electrical stimulation (tES)
Experimental: Active tDCS + Cognitive Remediation; Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.	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.; Other Name: transcranial electrical stimulation (tES)

Outcome Measures

Primary Outcome Measures :

1. Change in the Processing of Speed [ Time Frame: 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 :

1. Change in Driving Simulator Performance [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

UAB 1917 Clinic

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Pariya L Fazeli, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Pariya L. Fazeli, PhD, Principal investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02391311
• Other Study ID Numbers: K99AG048762 ( U.S. NIH Grant/Contract )
• First Posted: March 18, 2015
• Results First Posted: May 15, 2017
• Last Update Posted: May 15, 2017
• Last Verified: May 2017

Keywords provided by Pariya L. Fazeli, PhD, University of Alabama at Birmingham:

tDCS; Cognitive remediation therapy