Cognitive Training With and Without tDCS to Improve Cognition in HIV

NCT02647645 | Terminated Results

• 1 other identifier: 1203142F
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).

Conditions

HIV; Mild Neurocognitive Disorder

Outcome Measures

Primary Outcomes (1)

• Working Memory: Participants' Rate of Improvement

  Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.

  3 weeks

Secondary Outcomes (2)

• Center for Epidemiological Studies Depression Scale (CES-D)

  3 weeks

• Patient's Own Assessment of Function (PAOF)

  3 weeks

Study Arms (2)

Cognitive Training

ACTIVE COMPARATOR

Cognitive training Sham tDCS

Procedure: Cognitive training; Device: Sham transcranial direct current stimulation

Cognitive Training with tDCS

EXPERIMENTAL

Cognitive training Active tDCS

Device: Transcranial direct current stimulation; Procedure: Cognitive training

Interventions

Transcranial direct current stimulation DEVICE

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of 20 minutes each for 6 sessions over two weeks simultaneously with cognitive training.

Also known as: tDCS, Transcranial electric stimulation

Cognitive Training with tDCS

Cognitive training PROCEDURE

Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.

Also known as: Brain training

Cognitive Training; Cognitive Training with tDCS

Sham transcranial direct current stimulation DEVICE

Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of one minute to simulate active treatment applied in 6 sessions over two weeks.

Also known as: Sham tDCS, Sham transcranial electric stimulation

Cognitive Training

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Fluent in English
• Meets Frascati criteria for mild neurocognitive disorder

You may not qualify if:

• Left handed
• Presence of dementia
• Use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

NSU Psychiatry Research Office

Fort Lauderdale, Florida, 33328, United States

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Analyses were based on a small sample size. The sample size was smaller than originally planned, as the study was stopped when external funding for a more extensive and better controlled study was obtained.

Results Point of Contact

• Title: Raymond L Ownby, MD, PhD
• Organization: Nova Southeastern University

ro71@nova.edu

9542621481

Study Officials

• Raymond L Ownby, MD, PhD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 22, 2021
• Results First Posted: October 15, 2018

Record last verified: 2021-06

Locations

US (1)