A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

NCT02391311 | Completed Results DMC

• 1 other identifier: K99AG048762
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Aging

Keywords

tDCS; Cognitive remediation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Driving Simulator Performance

  baseline, 6 week posttest

Study Arms (2)

Sham tDCS + Cognitive Remediation

ACTIVE COMPARATOR

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)

Active tDCS + Cognitive Remediation

EXPERIMENTAL

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)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

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.

Also known as: transcranial electrical stimulation (tES)

Active tDCS + Cognitive Remediation; Sham tDCS + Cognitive Remediation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB 1917 Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Pariya L Fazeli, PhD
• Organization: UAB

plfazeli@uab.edu

205-996-0330

Study Officials

• Pariya L Fazeli, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-05

Locations

US (1)