40 Hz Light Neurostimulation for Patients With Depression (FELIX)

January 8, 2023 updated by: Klaus Martiny

A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression

Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Moreover, recent data suggest that 40 Hz light stimulation may induce neuroplasticity and reduce neuroinflammation.

In this study, the investigators aim to evaluate the antidepressant effects of 40 Hz light stimulation in Major Depressive Disorder (MDD). Patients will be exposed to 40 Hz invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) in a home setting for 1 hour each day.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Major depression is a major societal challenge worldwide and a substantial proportion of patients do not attain remission. Major depressive disorder (MDD) bears several key neurobiological similarities with Alzheimer's Disease, namely cognitive deficits, impaired neuroplasticity, neurodegeneration, and neuroinflammation. Inducing neuroplasticity and reducing neuroinflammation are thought to be key cellular targets in the treatment of MDD. However, 40 Hz light stimulation research in the context of MDD is limited.

In this double-blinded, randomized placebo-controlled trial the primary objective is to investigate the antidepressant effect of a non-invasive neurostimulation therapy using a 40 Hz masked flickering light. This study utilizes a novel way of masking light by alternating the spectral composition of white light, resulting in the flicker unnoticeable to human perception.

The primary outcome measure of this study is the estimated difference in the Hamilton Depression Rating sub-scale (HAM-D6) scores between groups at week 6. Furthermore, investigators want to assess whether 40 Hz masked flickering light therapy produces a similar early shift in neural and cognitive response to emotional information seen with antidepressant therapy and whether this predicts treatment efficacy. Suicidal ideation, sleep patterns, and quality of life will be also investigated in order to evaluate the 40 Hz masked flickering light stimulation effects on other symptoms of depression. Explorative analysis of the EEG data will be performed from baseline to week 6 for the further development and validation of EEG-based biomarkers.

A total of 60 participants will be enrolled for a six weeks treatment period followed by a two weeks follow-up period. Participants will be recruited from a psychotherapeutic outpatient unit. Medication should be unchanged for the last 4 weeks and during the study period.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Mental Health Centre Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects between 18 and 75 years of age.
  2. Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5
  3. Subjects with an MDI score > 21 at screening
  4. Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial.
  5. Subjects, who are willing to comply with the scheduled plan and are able to use the device for 1 hour per day for 6 weeks.
  6. Subjects who can understand the oral and written study information and willing to sign an informed consent.

Exclusion Criteria:

  1. Subjects with a history of photosensitive migraines and/or epileptic seizures
  2. Subjects with a known eye disorder that might be sensitive to light treatment.
  3. Subjects with a known history of bipolar disorder according to DSM-5 criteria
  4. Subjects with suicidal ideation corresponding to a score of 2 or more on the HAM-D 17 scale item 3 or if the patient or investigator is uncertain of the degree of suicidal risk
  5. Subjects with current psychotic symptoms. However, subjects with a prior psychotic depression or subjects with an actual psychotic depression episode that at the time of informed consent no longer fulfills the psychosis criteria are allowed to participate.
  6. Subjects with current drug or alcohol dependence based on their medical records or the M.I.N.I. interview.
  7. Subjects with a known history of borderline personality disorder
  8. Subjects currently enrolled in another investigational treatment study.
  9. Subjects with progressive neurodegenerative or neoplastic disease.
  10. Subjects who are unable to understand the study procedures or handling of the NSS device.
  11. Subjects who are pregnant at the time of inclusion or unsafe contraception in women of fertile age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Neurostimulation System (NSS)
Exposure to the NSS device set to 40 Hz invisible spectral flicker 1 hour a day
Device: Neurostimulation System (NSS): Active Setting
Exposure to the active device for 1 hour a day for 6 weeks
Placebo Comparator: Sham Neurostimulation System (NSS)
Exposure to the NSS device set to continuous color-matched white light for 1 hour a day
Device: Neurostimulation System (NSS): Sham Setting
Exposure to the sham device for 1 hour a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6)
Time Frame: Baseline and week 6
The HAM-D6 scale is designed to rate the severity of depression by a healthcare professional. The assessment scale contains 6 items pertaining to the symptoms of depression experienced over the week. The primary endpoint is the mean difference in scores between treatments at baseline and week 6. The score range is from, 0-24 (24=highest depression level).
Baseline and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported depression symptoms measured by Major Depression Inventory (MDI)
Time Frame: Baseline, week 1, 3, 6 and 8.
The MDI is a depression self-assessment questionnaire. It consists of the 10 ICD-10 symptoms for depression. The sum of 10 questions indicates the degree of depression. The score range is from 0-50 (50=highest depression level).
Baseline, week 1, 3, 6 and 8.
Cognition measured by Facial Expression Recognition Test (FERT)
Time Frame: Baseline, week 1 and 6

Assessing attention and recognition of emotional facial expressions using the FERT.

The outcome is accuracy (% correct expressions identified, range: 0-100, higher is better) and response times for accurate identifications (milliseconds, range can vary quite a bit, smaller number is better because it reflect higher speed).
Baseline, week 1 and 6
Cognition measured by Emotional Categorization and Memory test (ECMT)
Time Frame: Baseline, week 1 and 6
Assessing self-referent memory for emotional words using the ECMT. Outcome is response times for correct identifications during encoding phase (milliseconds, smaller better) and for recall phase: number of positive and negative words recalled (higher is better)
Baseline, week 1 and 6
Cognition measured by Screen for Cognitive Impairment in Psychiatry (SCIP)
Time Frame: Baseline, week 1 and 6
Non-emotional cognition is investigated with the SCIP. Outcomes is total score as well as scores for the five subtests, in all cases higher is better (numbers correct)
Baseline, week 1 and 6
Cognition measured by Trail Making Test B (TMT- B)
Time Frame: Baseline, week 1 and 6
Non-emotional cognition investigated with the Trail Making Test B (TMT- B). Outcome is time in seconds to complete the task, lower is better (higher speed)
Baseline, week 1 and 6
Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, week 3, 6 and 8
PSQI consist of seven component scores that are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A cut-off of 5 is recognized a indicative of sleep problems.
Baseline, week 3, 6 and 8
Sleep duration
Time Frame: Baseline, week 3, 6 and 8
Average sleep duration assessed over last 7 days will be logged by the participants using a sleep diary.
Baseline, week 3, 6 and 8
Sleep timing
Time Frame: Baseline, week 3, 6 and 8
Average sleep timing will be assessed over last 7 days logged by the participants using a sleep diary.
Baseline, week 3, 6 and 8
Quality of Life measured by WHO quality of life index (WHO-5)
Time Frame: Baseline, week 3,6 and 8
The WHO-5 score ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life. A 10% difference indicates a significant change.
Baseline, week 3,6 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaus Martiny

Collaborators

Technical University of Denmark
OptoCeutics

Investigators

  • Principal Investigator: Klaus Martiny, Senior Consultant at Psychiatric Centre Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FELIX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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