A Novel Neurorehabilitation Approach for Cognitive Aging With HIV (HtDCS)
12 maj 2017 uppdaterad av: Pariya L. Fazeli, PhD, University of Alabama at Birmingham
Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)
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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- UAB 1917 Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
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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.
Andra namn:
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Experimentell: 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.
|
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in the Processing of Speed
Tidsram: baseline, 6 week posttest
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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.
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baseline, 6 week posttest
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Driving Simulator Performance
Tidsram: baseline, 6 week posttest
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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.
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baseline, 6 week posttest
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Pariya L Fazeli, PhD, University of Alabama at Birmingham
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2015
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
5 mars 2015
Först inskickad som uppfyllde QC-kriterierna
12 mars 2015
Första postat (Uppskatta)
18 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- K99AG048762 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .