Mild Traumatic Brain InjuryNCT06109909
Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
A study testing Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation in people with Mild Traumatic Brain Injury and Photophobia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Photophobia
- What is being tested?
- Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65
- Documented history of mTBI at least 6 months prior to initial study visit
- Documented symptoms of photosensitivity
- Eye exam within the last 12 months documenting best-corrected acuity of 20/20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test
Who cannot join
- History of strabismus or amblyopia
- Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes
- Previous or current history of retinal or optic nerve pathology in one or both eyes
- History of stroke and/or visual neglect
- History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)
- History of epilepsy or seizures
Show all 10Show fewer
- History of motor tics
- Current use of medications or substances that may severely affect pupillary response and/or increase photosensitivity
- Individuals with impaired decision-making capacity
- Illiterate or no English language proficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Francesca C Fortenbaugh, PhD, 857-364-4362, Francesca.Fortenbaugh@va.gov
Francesca C Fortenbaugh, PhD
About this study
Official title: A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.
Read the detailed description
Photosensitivity (PS) is one of the more common sequelae of TBI, with over 50% of TBI patients reporting some level of PS in the acute and/or chronic stages. PS can range from mild to severe and can significantly impair social, physical, and cognitive functioning, as well as rehabilitation outcomes. While spectacle chromatic filters are conventionally used to alleviate symptoms, they are not designed to resolve issues with PS and have been associated with lower symptom recovery over time, underscoring the need to develop more effective, non-invasive treatment options that can reduce or eliminate PS. Recent work has shown that neurofeedback interventions, such as Low Intensity Pulse-Based Transcranial Electrical Stimulation (LIP-tES) may be effective in treating post-concussive symptoms and a preliminary case study from the investigators' research group suggests that LIP-tES may also be able to reduce PS symptoms in Veterans with a history of mild TBI. However, both the mechanism by which LIP-tES alters brain activity and alleviates symptoms across a range of disorders remains unclear as does the neurobiological basis of PS associated with mTBI and psychiatric comorbidities commonly seen in today's Veteran population. These knowledge gaps represent important limitations both for the clinical characterization of PS in Veterans and development/optimization of novel treatment options. This proposal will take an important first step in addressing these two important knowledge gaps. Aim 1: Complete a preliminary study testing the feasibility and acceptability of a novel LIP-tES intervention designed to reduce severity of PS in patients with a history of mTBI. Extending a recent case study completed by the investigators' research group, the investigators will complete a pilot study of LIP-tES for the treatment of PS in Veterans with a history of mTBI. The investigators will track recruitment capability (participants screened vs. enrolled, attrition rates and reasons for attrition), acceptability and suitability of the intervention, evaluate suitability of the sham procedure the investigators developed, and gain preliminary evaluation of participant responses to the intervention. Aim 2: Assess neurophysiological markers of PS and changes associated with LIP-tES intervention using resting-state fMRI. A subset of the participants will complete two MRI scans during the initial visit after the last LIP-tES or sham session. Preliminary work from the investigators' laboratory has identified a sparse connectome of regions that are predictive of moderate/severe PS ratings in a polymorbid sample of Veterans from the Translational Research Center for TBI and Stress Disorders (TRACTS) longitudinal cohort study. Extending this work, the investigators will test whether classification models using this previously identified connectome will correctly identify individuals who report a reduction in PS after treatment and whether connections are predictive of PS severity. By examining resting-state functional connectivity prior to and after completion of LIP-tES, the proposed study aims to increase the understanding of the underlying pathophysiological mechanisms of PS in mTBI and the mechanism by which LIP-tES may alleviate these symptoms.
- Conditions
- Mild Traumatic Brain Injury, Photophobia
- Being tested
- Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation
- Keywords
- photophobia, mild traumatic brain injury
- Medical subject headings
- Brain Concussion, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical StimulationDevice
Also called LIP-tES intervention
The EEG interface device is a J\&J Engineering 1-330 C2 box. The software used to determine LIP-tES feedback patterns was developed by Neurogen High Performance Neurofeedback. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+,A-,B+,B-), with respect to the Common Neck Reference. During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scale to record EEG signals. All four (A+,A-,B+,B-) electrodes are involved in applying weak electrical pulses back to the brain (feedback process). The brief feedback pulse (~100mV) is adaptive and determined based on the offset of the frequency spectrum recorded across the left and right hemisphere (A vs. B) electrodes in the time window immediately prior to stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Half of the participants will be blindly assigned to receive 12 sessions of LIP-tES intervention over 6 weeks. A subset of these participants will also complete a resting-state MRI scan during the initial session (prior to LIP-tES intervention) and after their final LIP-tES intervention. Receives: Device: Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation |
| Sham Treatment | Sham comparator | Half of the participants will be blindly assigned to receive 12 sessions of a sham intervention that will mirror all aspects of the LIP-tES intervention except that no neurofeedback pulses will be delivered. A subset of these participants will also complete a resting-state MRI scan at the beginning of the initial session and at the end of the 12th session. Receives: Device: Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Utah Photophobia Symptom Impact Scale (UPSIS)
The UPSIS questionnaire is a 17-item questionnaire designed to quantitatively assess photosensitivity symptoms and their impact on activities of daily living. Scores range from 0-80 with higher values indicating more severe photosensitivity symptoms.
Measured: Baseline and again every two weeks through end of treatment, average of 6 weeks
Secondary outcomes (9)
Stimulation Related Sensations Questionnaire (SRSQ)
The SRSQ will be administered to participants after the LIP-tES or sham session is complete. Results will be used to assess if participants report different sensations across conditions to examine if sham condition is appropriate control condition.
Measured: Baseline treatment visit
Change from Baseline in Neurobehavioral Symptom Inventory (NSI)
The NSI will be administered as a measure of general post-concussive symptoms
Measured: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Headache Impact Test (HIT-6)
The HIT-6 will be administered to measure changes in headache frequency and severity over prior month.
Measured: Baseline and again at study completion, an average of 6 weeks
Qualitative Assessment of Study Recruitment Capability
Qualitative assessment of ability to recruit participants into the study by examining recruitment rates and reported obstacles to recruitment over study period. Assessment will result in decision that recruitment capabilities are suitable or unsuitable for additional study with no change to targeted population with same inclusion/exclusion criteria.
Measured: End of study data collection, approximately 2 years
Qualitative Assessment of Acceptability of Data Collection Methods
Qualitative assessment of the suitability of data collection procedures by examining the retention and follow-up rates as the participants moved through the study and intervention, adherence rates to study procedures, barriers to study participation reported by participants over the course of the study. Assessment will result in decision that current study protocol is suitable or unsuitable for additional study with no change to study design.
Measured: End of study data collection, approximately 2 years
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 will be administered to measure changes in PTSD symptom severity.
Measured: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS)
The DASS questionnaire will be administered to measure changes in severity of depression, anxiety, and stress symptoms.
Measured: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be administered to provide a measure of changes in global sleep quality.
Measured: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Short Form McGill Pain Questionnaire
This questionnaire will be administered to provide a general measure of changes in chronic pain.
Measured: Baseline and again at study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jan 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After consent, participants will be randomly assigned to either the LIP-tES intervention or sham control group. Participants will complete 12 sessions over 6 weeks during which photosensitivity symptoms will be tracked using the Utah Photophobia Symptom Impact Scale (UPSIS). A subset of participants will also complete a resting-state MRI scan session during the initial visit and again during the 12th visit. A follow-up phone call will be placed after a 6 week wash-out period. Group assignment will be disclosed at this time and participants in the sham condition who would like to receive the LIP-tES intervention will be able to return for an additional 12 sessions over 6 weeks during which they will receive LIP-tES and photosensitivity symptoms will be tracked using the UPSIS questionnaire.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Francesca C Fortenbaugh, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109909
- Sponsor's protocol ID
- C4374-P
- Status last verified
- Dec 2025
- First submitted
- 25 Oct 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06109909
- Acronym / sponsor ID
- C4374-P
- Conditions
- Mild Traumatic Brain Injury, Photophobia
- Keywords
- photophobia, mild traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.
Detailed description
Photosensitivity (PS) is one of the more common sequelae of TBI, with over 50% of TBI patients reporting some level of PS in the acute and/or chronic stages. PS can range from mild to severe and can significantly impair social, physical, and cognitive functioning, as well as rehabilitation outcomes. While spectacle chromatic filters are conventionally used to alleviate symptoms, they are not designed to resolve issues with PS and have been associated with lower symptom recovery over time, underscoring the need to develop more effective, non-invasive treatment options that can reduce or eliminate PS. Recent work has shown that neurofeedback interventions, such as Low Intensity Pulse-Based Transcranial Electrical Stimulation (LIP-tES) may be effective in treating post-concussive symptoms and a preliminary case study from the investigators' research group suggests that LIP-tES may also be able to reduce PS symptoms in Veterans with a history of mild TBI. However, both the mechanism by which LIP-tES alters brain activity and alleviates symptoms across a range of disorders remains unclear as does the neurobiological basis of PS associated with mTBI and psychiatric comorbidities commonly seen in today's Veteran population. These knowledge gaps represent important limitations both for the clinical characterization of PS in Veterans and development/optimization of novel treatment options. This proposal will take an important first step in addressing these two important knowledge gaps. Aim 1: Complete a preliminary study testing the feasibility and acceptability of a novel LIP-tES intervention designed to reduce severity of PS in patients with a history of mTBI. Extending a recent case study completed by the investigators' research group, the investigators will complete a pilot study of LIP-tES for the treatment of PS in Veterans with a history of mTBI. The investigators will track recruitment capability (participants screened vs. enrolled, attrition rates and reasons for attrition), acceptability and suitability of the intervention, evaluate suitability of the sham procedure the investigators developed, and gain preliminary evaluation of participant responses to the intervention. Aim 2: Assess neurophysiological markers of PS and changes associated with LIP-tES intervention using resting-state fMRI. A subset of the participants will complete two MRI scans during the initial visit after the last LIP-tES or sham session. Preliminary work from the investigators' laboratory has identified a sparse connectome of regions that are predictive of moderate/severe PS ratings in a polymorbid sample of Veterans from the Translational Research Center for TBI and Stress Disorders (TRACTS) longitudinal cohort study. Extending this work, the investigators will test whether classification models using this previously identified connectome will correctly identify individuals who report a reduction in PS after treatment and whether connections are predictive of PS severity. By examining resting-state functional connectivity prior to and after completion of LIP-tES, the proposed study aims to increase the understanding of the underlying pathophysiological mechanisms of PS in mTBI and the mechanism by which LIP-tES may alleviate these symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After consent, participants will be randomly assigned to either the LIP-tES intervention or sham control group. Participants will complete 12 sessions over 6 weeks during which photosensitivity symptoms will be tracked using the Utah Photophobia Symptom Impact Scale (UPSIS). A subset of participants will also complete a resting-state MRI scan session during the initial visit and again during the 12th visit. A follow-up phone call will be placed after a 6 week wash-out period. Group assignment will be disclosed at this time and participants in the sham condition who would like to receive the LIP-tES intervention will be able to return for an additional 12 sessions over 6 weeks during which they will receive LIP-tES and photosensitivity symptoms will be tracked using the UPSIS questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical StimulationHalf of the participants will be blindly assigned to receive 12 sessions of LIP-tES intervention over 6 weeks. A subset of these participants will also complete a resting-state MRI scan during the initial session (prior to LIP-tES intervention) and after their final LIP-tES intervention. |
| Sham Treatment | Sham comparator | Device: Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical StimulationHalf of the participants will be blindly assigned to receive 12 sessions of a sham intervention that will mirror all aspects of the LIP-tES intervention except that no neurofeedback pulses will be delivered. A subset of these participants will also complete a resting-state MRI scan at the beginning of the initial session and at the end of the 12th session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-65
- Documented history of mTBI at least 6 months prior to initial study visit
- Documented symptoms of photosensitivity
- Eye exam within the last 12 months documenting best-corrected acuity of 20/20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test
Key exclusion criteria (10 listed)
- History of strabismus or amblyopia
- Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes
- Previous or current history of retinal or optic nerve pathology in one or both eyes
- History of stroke and/or visual neglect
- History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical StimulationAlso: LIP-tES interventionThe EEG interface device is a J\&J Engineering 1-330 C2 box. The software used to determine LIP-tES feedback patterns was developed by Neurogen High Performance Neurofeedback. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+,A-,B+,B-), with respect to the Common Neck Reference. During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scale to record EEG signals. All four (A+,A-,B+,B-) electrodes are involved in applying weak electrical pulses back to the brain (feedback process). The brief feedback pulse (~100mV) is adaptive and determined based on the offset of the frequency spectrum recorded across the left and right hemisphere (A vs. B) electrodes in the time window immediately prior to stimulation. | Device | Neurofeedback, Sham Treatment |
Primary outcome
Change in Utah Photophobia Symptom Impact Scale (UPSIS)
Time frame: Baseline and again every two weeks through end of treatment, average of 6 weeks
The UPSIS questionnaire is a 17-item questionnaire designed to quantitatively assess photosensitivity symptoms and their impact on activities of daily living. Scores range from 0-80 with higher values indicating more severe photosensitivity symptoms.
9 secondary outcomes
Stimulation Related Sensations Questionnaire (SRSQ)
Time frame: Baseline treatment visit
Change from Baseline in Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Headache Impact Test (HIT-6)
Time frame: Baseline and again at study completion, an average of 6 weeks
Qualitative Assessment of Study Recruitment Capability
Time frame: End of study data collection, approximately 2 years
Qualitative Assessment of Acceptability of Data Collection Methods
Time frame: End of study data collection, approximately 2 years
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS)
Time frame: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and again at study completion, an average of 6 weeks
Change from Baseline in Short Form McGill Pain Questionnaire
Time frame: Baseline and again at study completion, an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca C Fortenbaugh, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation in people with Mild Traumatic Brain Injury and Photophobia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca C Fortenbaugh, PhD ((857) 364-4362, Francesca.Fortenbaugh@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Utah Photophobia Symptom Impact Scale (UPSIS) (time frame: Baseline and again every two weeks through end of treatment, average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.