A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Speed of Processing Training in Adults With HIV

NCT02758093

HIV Cognition - Other Impaired Driving

COMPLETED NA

Individualized Cognitive Training in HIV

NCT03122288

HIV-Associated Cognitive Motor Complex Aging Cognitive Impairment +5 more

COMPLETED NA

Improving Memory Performance by Applying Cognitive Training

NCT02216591

HIV

COMPLETED NA

Working Memory Training for People Aging with HIV

NCT06699927

Cognitive Change

RECRUITING EARLY_PHASE1

Neural Correlates of Working Memory Training for HIV Patients

NCT02602418

HIV Infection

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

transcranial electrical stimulation (tES)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No