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

The University of Alabama at Birmingham

Status: Completed

Conditions: Aging; HIV

Treatments: Device: transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02391311

K99AG048762

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Sham tDCS + Cognitive Remediation

Active Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation (tDCS)

Active tDCS + Cognitive Remediation

Experimental group

Description:

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.

Treatment:

Device: transcranial direct current stimulation (tDCS)