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Studies

Interventional Recruiting

NCT07602296 on ClinicalTrials.gov

Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies

Official title: Effect of Transcranial Photobiomodulation on Clinical Symptoms, Quality of Life and Cerebral Connectivity Modifications in Dementia With Lewy Bodies

  • Sponsor: Hôpital d'Hautepierre
  • Enrollment: 40 (Estimated)
  • Study start: 2026-09-16 (Actual)
  • Primary completion: 2029-05-01 (Estimated)
  • Study completion: 2029-05-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Supportive Care

Brief Summary

Dementia with Lewy bodies (DLB) is a neurodegenerative disease diagnosed primarily based on the presence of cognitive decline, which may include difficulties with memory, attention, and more. Additionally, at least two of the following symptoms are needed for a probable diagnosis of DLB, and at least one for a possible DLB diagnosis (McKeith et al. 2017 and 2020):

* Fluctuations in cognition, attention, and/or alertness
* Visual hallucinations
* Spontaneous parkinsonism
* REM sleep behavior disorder

Patients with DLB can experience cognitive deficits that can fluctuate and can vary for each patient. These may include deficits in memory, executive functions (planning and organizing), attention, visual processing, and language.

This study aims to evaluate the effect of red-light therapy, delivered using a helmet that contains small LED lights, in patients with DLB.

Participants' cognitive functions, clinical symptoms, quality of life and functional cerebral connectivity will be evaluated before starting therapy and again after three and six months of twice daily therapy use. As DLB also indirectly affects caregivers, the caregiver's quality of life and burden will also be evaluated before and at three and six months of therapy use by the participant.

The study's inclusion period is 24 months and the duration of participation for each patient is 8 months (+/-10 days) maximum.

Conditions

  • Photobiomodulation
  • Dementia With Lewy Bodies

Intervention / Treatment

  • Device: LUCIOLE CAP
  • Device: LUCIOLE CAP (sham version)

Primary Outcome Measures

  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Measurements done right before start of PBM (at month 0 (M0)), after 3 months of PBM (M3), after six months of PBM (M6), and one month after end of PBM (M7))
    (Randolph et al., 1998)

Countries

France

Locations and Investigators

  • Hôpitaux Universitaires de Strasbourg, Strasbourg, France (Recruiting)