The "Light for the Brain" Study

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• Cognitive Dysfunction 3,843

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 47 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Study arms

• Experimental
  Intervention light

  30 minutes of intervention systematic light exposure daily for 4 weeks.

  Device: Intervention systematic light exposure

• Active comparator
  Comparison light

  30 minutes of comparison systematic light exposure daily for 4 weeks.

  Device: Comparison systematic light exposure

Interventions

• DeviceIntervention systematic light exposure

  Bright light using Litebook device.

• DeviceComparison systematic light exposure

  Dim light using modified Litebook device.

Primary outcomes

1. Cognitive Functioning (Neuropsychological Tests)

   Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.

   Time frame: Baseline to end-of-intervention to 8 weeks after the intervention

Secondary outcomes

1. Circadian Activity Rhythms (Actigraphy)

   F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.

   Time frame: Baseline to end of intervention to 8 weeks later

2. Sleep Quality (Pittsburgh Sleep Quality Index)

   The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality

   Time frame: Baseline, mid intervention, end of intervention, 8 weeks later

3. Fatigue (FACIT-fatigue)

   This is a 13-item measure of fatigue.

   Time frame: Baseline, mid-intervention, end of the intervention, 8 weeks later

4. Depressed Mood (CESD)

   The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.

   Time frame: Baseline, Mid-intervention, End of intervention, 8 weeks later

5. Neurobehavioral Functioning (Frontal Systems Behavioral Scale)

   Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.

   Time frame: Baseline, mid-intervention, end-of-intervention, 8 weeks later

6. Quality of Life (FACT-BMT)

   This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

   Time frame: Baseline, End of intervention, 8 weeks post-intervention

7. Interleukin-6

   Serum cytokine IL-6 in pg/mL

   Time frame: Baseline and end-of-intervention

8. Pro-inflammatory Cytokine - TNF Alpha

   Serum cytokine TNF-α in pg/mL

   Time frame: Baseline and end-of-intervention

9. C-Reactive Protein

   C-reactive protein in mg/L

   Time frame: Baseline and end-of-intervention

10. Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)

    The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.

    Time frame: Baseline, mid-intervention, end of intervention, 8 weeks after intervention

Other outcomes

1. Treatment Satisfaction (FACT-TS)

   Range between 0 and 5, with 5 meaning higher treatment satisfaction

   Time frame: During the 4th week of the intervention

2. Credibility/Expectancy (Credibility/Expectancy Questionnaire)

   Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.

   Time frame: Baseline

3. Usage of Light Box (Integrated Meter Measurement and Litebook Log)

   Length of time light box has been used.

   Time frame: Throughout intervention period (4 weeks)

4. Chronotype (Morningness-eveningness Questionnaire)

   Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.

   Time frame: Baseline

Baseline characteristics

Publications

• Wu LM, Valdimarsdottir HB, Amidi A, Reid KJ, Ancoli-Israel S, Bovbjerg K, Fox RS, Walker L, Matharu A, Kaseda ET, Galvin JP, Adekola K, Winkel G, Penedo F, Redd WH. Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors. J Biol Rhythms. 2022 Oct;37(5):471-483. doi: 10.1177/07487304221107833. Epub 2022 Jul 29. Erratum In: J Biol Rhythms. 2022 Oct;37(5):NP1. doi: 10.1177/07487304221120697. PubMed 35904252 ↗

Study documents

• Protocol, analysis plan and consent form · Jul 16, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No