Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors

29. juli 2026 opdateret af: Hon K. Yuen, PhD, University of Alabama at Birmingham
The goal of the study is to understand how well cognitive training improves reaction time in people with head and neck cancer (HNC). Aim 1. Evaluate the preliminary clinical effectiveness of a 10-week home- and video game-based SOPT on cognitive functioning and driving performance in HNC survivors. This study will include completing five questionnaires and simulated driving in a simulator at two different times, 10 weeks of participating in 2 sessions per week of video-game cognitive training at home and being interviewed once at the end of the 10-week training.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

If participants agree to participate in the study by signing the informed consent, participants will be randomly assigned (similar to flipping a coin) to one of the two video game cognitive exercise groups. The only difference between these two groups is the intensity of training on reaction time to video game events.

participants will complete questionnaires (socio-demographic information, four short cognitive assessments) and a driving assessment using a high-fidelity motion-based virtual reality driving simulator in the UAB Driver Simulation Lab at baseline. After completing the baseline cognitive and driving evaluations, participants will receive an electronic tablet loaded with access to the assigned video game program and a workbook with instructions and explanations. A staff member will assist participants in logging in, demonstrate the video game cognitive exercises, and show participants how to play a trial game session.

At home, participants will complete 30-minute video game-based cognitive exercises twice weekly for 10 weeks (20 sessions, totaling 10 hours). The software will automatically record the actual session duration. One week after the baseline appointment, the staff will contact participants to address any technical problems. The staff will then contact participants monthly to monitor progress and answer study-related questions.

After the 10-week video game cognitive exercise program, participants will be invited to the UAB Driver Simulation Lab to complete the four short cognitive assessments and a driving assessment as participants did 10 weeks ago.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Hon Yuen
  • Telefonnummer: 12059346301
  • E-mail: yuen@uab.edu

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • confirmed HNC diagnosis
  • aged ≥ 18 years of all racial, ethnic, and sex/gender categories
  • ≥ 6 months post radiation or chemoradiation
  • self-reported CRCI, defined as a score of ≥ 60 in the FACT-Cog Perceived Cognitive Impairment subscale
  • thyroid-stimulating hormone levels within normal limits
  • visual acuity of at least 20/40 using a Snellen eye chart
  • functional peripheral vision as indicated by the confrontation field test
  • functional hearing sufficient to engage in daily conversation in English for ≥ 15 minutes
  • intact lower extremity function (Rapid Pace Walk test ≤ 9 sec)
  • stable home internet
  • sufficient English proficiency to read and understand informed consent materials

Exclusion Criteria:

  • significant neurologic or psychiatric comorbidities, including psychotic disorders, bipolar disorders, Alzheimer's disease or related dementias, developmental disorders, seizure disorders, vestibular disorders, prior brain tumor or brain surgery, or poorly controlled metabolic disease
  • current use of antipsychotic or mood-stabilizing medications due to potential effects on driving performance
  • anticipated life expectancy of < 6 months based on physician prognosis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Speed of Processing Training
The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
Sham-komparator: Home-Based Sham Training
The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Useful Field of View
Tidsramme: change from baseline in speed of processing at 10 weeks
Useful Field of View (UFOV) examines visual attention and memory that require rapid recognition and response to simultaneous demands in both the central and peripheral visual fields. The test consists of four increasingly complex subtests. In each subtest, stimulus presentations ranging from 17-500 milliseconds are displayed to determine the speed at which visual information is processed. In each subtest, a double staircase method is used to determine the presentation speed at which participants correctly complete the task 75% of the time. Lower scores (fewer milliseconds to correctly perceive the target) reflect faster SOP.
change from baseline in speed of processing at 10 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hon Yuen, University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

3. september 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

26. juli 2026

Først indsendt, der opfyldte QC-kriterier

29. juli 2026

Først opslået (Faktiske)

31. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-300017007
  • UAB (Anden identifikator: UAB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Adhering to laws like HIPAA or GDPR, which strictly prohibit the unauthorize distribution of personally identifiable information

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner