ConcussionPhase 2/3NCT07507214
Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
A Phase 2/3 study testing ONE-D TMS protocol and d-cycloserine (125 mg) in people with Concussion and Depression, run by University of Florida at 1 site in United States.
Trial summary
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Concussion, Depression
- What is being tested?
- ONE-D TMS protocol and d-cycloserine (125 mg)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jun 2028
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female athletes, both recreational and professional
- ages 18-65 years old
- Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present
- Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater
- Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks
Who cannot join
- Pregnant or breast-feeding individuals
- History of seizures or epilepsy
- Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)
- Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)
- History of bipolar disorder
- Pacemakers or implanted defibrillators
Show all 11Show fewer
- Allergy or other contraindications to d-cycloserine
- Other contraindications as determined by PI
- Unable to provide informed consent due to language or other barriers
- Incarceration
- Biological male gender
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
UF World Equestrian Center
Ocala, Florida, 34482
Sara Gould, MD, 352-273-7381, gouldsj@ortho.ufl.edu
Virginia Dykes, DAT,LAT,ATC, 352-273-7343, jacksve@ortho.ufl.edu
About this study
Official title: Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits:
Previous studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.
Read the detailed description
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options.
The objective of this application is to treat female athletes with depression and concussion with the Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D) protocol.7 This is an innovative, one-day duration TMS treatment for depression. We propose to utilize tradition depression assessments, such as the Patient Health Questionnaire 9 (PHQ-9)8, as well as athlete-specific symptom inventories, including the Post-Concussion Symptom Scale (PCSS)9 and the Sport Mental Health Assessment Tool 1 (SMHAT-1)10 surveys to test our central hypothesis that female athletes with a history of concussion and depression will experience symptom improvement in depression inventories as well as athlete-specific symptom domains. We will assess associations between TMS treatment and depression through PHQ-9 and SMHAT-1 and associations between TMS treatment and concussion symptoms through PCSS.
Treatment Delivery
Once the subject completes the consent process, they will begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).The UF-World Equestrian center (WEC) pharmacy will dispense this medication prior to the study visit. The WEC pharmacy is located in the same physical building as the clinic where the treatment will take place. Patients will obtain their medication from the pharmacy prior to their treatment appointment. The medications will be consumed one hour (50-70 min) prior to the start of the first treatment under study staff supervision. After consuming the medication, the participant will begin baseline symptom inventory scores, including Sport Concussion Office Assessment Tool 6 (SCOAT6), Post-Concussion Symptom Scale (PCSS), Patient Health Questionnaire 9 (PHQ-9) and the Sport Mental Health Assessment Tool 1 (SMHAT-1).18 The treatment protocol consists of an AMPA device delivering accelerate theta-burst stimulation for a total of 600 pulses over 3 minute sessions.9 The treatment is repeated every 30 minutes (± 3 min) for a total of 20 sessions over 9.5 hours in a single day. The treatment will be performed by the research assistant or the research coordinator under PI supervision.
The Ampa TMS system was selected for this study as it uses anatomic locations to guide treatment targets, as opposed to other commercially available TMS systems that require FMRI imaging to create individual treatment plans. AMPS technology is FDA approved to be utilized in this manner.
Treatment parameters:
- 3 Hz x 600 pulses
- 90% of motor threshold for contralateral upper extremity
Symptom inventories will be recorded at weeks 3, 6, and 12 after the treatment session. The surveys will be collected through Redcap. Due to the nature of the surveys, the subjects will be called by a member of the research team during business hours so that if any subject is deemed positive for suicidality, the research team can immediately contact the PI and refer patient to treatment as stated in DSMB/DSMP. This may include a 911 welfare check. At the 12-week mark, the subjects will be called via zoom video call to complete the SCOAT6.
- Mez J, Daneshvar DH, Kiernan PT, et al. Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football. JAMA. 2017;318(4):360-370. doi:10.1001/jama.2017.8334
- Sandhu MRS, Schonwald A, Boyko M, et al. The association between female sex and depression following traumatic brain injury: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2025;168:105952. doi:10.1016/j.neubiorev.2024.105952
- McKee AC, Mez J, Abdolmohammadi B, et al. Neuropathologic and Clinical Findings in Young Contact Sport Athletes Exposed to Repetitive Head Impacts. JAMA Neurol. 2023;80(10):1037-1050. doi:10.1001/jamaneurol.2023.2907
- D'Lauro C, Jones ER, Swope LM, Anderson MN, Broglio S, Schmidt JD. Under-representation of female athletes in research informing influential concussion consensus and position statements: an evidence review and synthesis. Br J Sports Med. Published online July 18, 2022:bjsports-2021-105045. doi:10.1136/bjsports-2021-105045
- Meier TB, Giraldo-Chica M, España LY, et al. Resting-State fMRI Metrics in Acute Sport-Related Concussion and Their Association with Clinical Recovery: A Study from the NCAA-DOD CARE Consortium. J Neurotrauma. 2020;37(1):152-162. doi:10.1089/neu.2019.6471
- Milano BA, Palm S, Burke MJ, et al. Lesion network localization of functional and somatic symptoms. MedRxiv Prepr Serv Health Sci. Published online March 7, 2025:2025.03.06.25323494. doi:10.1101/2025.03.06.25323494
- Vaughn DA, Marino B, Engelbertson A, et al. Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D): An open-label case series. Transcranial Magn Stimul. 2025;5. doi:10.1016/j.transm.2025.100200
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613. doi:10.1046/j.1525-1497.2001.016009606.x
- Kontos AP, Elbin RJ, Schatz P, et al. A revised factor structure for the post-concussion symptom scale: baseline and postconcussion factors. Am J Sports Med. 2012;40(10):2375-2384. doi:10.1177/0363546512455400
- Gouttebarge V, Bindra A, Blauwet C, et al. International Olympic Committee (IOC) Sport Mental Health Assessment Tool 1 (SMHAT-1) and Sport Mental Health Recognition Tool 1 (SMHRT-1): towards better support of athletes' mental health. Br J Sports Med. 2021;55(1):30-37. doi:10.1136/bjsports-2020-102411
- Eagle SR, Womble MN, Elbin RJ, Pan R, Collins MW, Kontos AP. Concussion Symptom Cutoffs for Identification and Prognosis of Sports-Related Concussion: Role of Time Since Injury. Am J Sports Med. 2020;48(10):2544-2551. doi:10.1177/0363546520937291
- Broglio SP, Cantu RC, Gioia GA, et al. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014;49(2):245-265. doi:10.4085/1062-6050-49.1.07
- D'Lauro C, Jones ER, Swope LM, Anderson MN, Broglio S, Schmidt JD. Under-representation of female athletes in research informing influential concussion consensus and position statements: an evidence review and synthesis. Br J Sports Med. Published online July 18, 2022:bjsports-2021-105045. doi:10.1136/bjsports-2021-105045
- Musko PA, Demetriades AK. Are Sex Differences in Collegiate and High School Sports-Related Concussion Reflected in the Guidelines? A Scoping Review. Brain Sci. 2023;13(9):1310. doi:10.3390/brainsci13091310
- Harmon KG, Drezner J, Gammons M, et al. American Medical Society for Sports Medicine position statement: concussion in sport. Clin J Sport Med Off J Can Acad Sport Med. 2013;23(1):1-18. doi:10.1097/JSM.0b013e31827f5f93
- Rogers DL, Tanaka MJ, Cosgarea AJ, Ginsburg RD, Dreher GM. How Mental Health Affects Injury Risk and Outcomes in Athletes. Sports Health. 2024;16(2):222-229. doi:10.1177/19417381231179678
- Wolanin A, Hong E, Marks D, Panchoo K, Gross M. Prevalence of clinically elevated depressive symptoms in college athletes and differences by gender and sport. Br J Sports Med. 2016;50(3):167-171. doi:10.1136/bjsports-2015-095756
- Rogers DL, Tanaka MJ, Cosgarea AJ, Ginsburg RD, Dreher GM. How Mental Health Affects Injury Risk and Outcomes in Athletes. Sports Health. 2024;16(2):222-229. doi:10.1177/19417381231179678
- Reardon CL, Factor RM. Sport psychiatry: a systematic review of diagnosis and medical treatment of mental illness in athletes. Sports Med Auckl NZ. 2010;40(11):961-980. doi:10.2165/11536580-000000000-00000
- Mollica A, Greben R, Oriuwa C, Siddiqi SH, Burke MJ. Neuromodulation Treatments for Mild Traumatic Brain Injury and Post-concussive Symptoms. Curr Neurol Neurosci Rep. 2022;22(3):171-181. doi:10.1007/s11910-022-01183-w
- Patricios JS, Schneider KJ, Dvorak J, et al. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023;57(11):695-711. doi:10.1136/bjsports-2023-106898
- Coris EE, Moran B, Sneed K, et al. Stimulant Therapy Utilization for Neurocognitive Deficits in Mild Traumatic Brain Injury. Sports Health. 2022;14(4):538-548. doi:10.1177/19417381211031842
- Sharp T, Collins H. Mechanisms of SSRI Therapy and Discontinuation. Curr Top Behav Neurosci. 2024;66:21-47. doi:10.1007/7854_2023_452
- Billingham SAM, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013;13:104. doi:10.1186/1471-2288-13-104
- Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995;14(17):1933-1940. doi:10.1002/sim.4780141709
- Wennberg R, Hiploylee C, Tai P, Tator CH. Is Concussion a Risk Factor for Epilepsy? Can J Neurol Sci J Can Sci Neurol. 2018;45(3):275-282. doi:10.1017/cjn.2017.300
- Fitzgerald PB. An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. J Affect Disord. 2020;276:90-103. doi:10.1016/j.jad.2020.06.067
- Mathias CW, Michael Furr R, Sheftall AH, Hill-Kapturczak N, Crum P, Dougherty DM. What's the harm in asking about suicidal ideation? Suicide Life Threat Behav. 2012 Jun;42(3):341-51.
- Conditions
- Concussion, Depression
- Being tested
- ONE-D TMS protocol and d-cycloserine (125 mg)
- Medical subject headings
- Brain Concussion, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONE-D TMS protocol and d-cycloserine (125 mg)Device
Begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).
| Study group | Role | What they receive |
|---|---|---|
| Female athletes with a history of concussion and depression | Experimental | Participants are treated with ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg). Receives: Device: ONE-D TMS protocol and d-cycloserine (125 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores
These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.
Measured: Baseline, 12 weeks
Sport Mental Health Assessment Tool 1 (SMHAT-1) depression symptom inventory scores
These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks
Secondary outcomes (2)
Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms
This inventory monitors concussion symptoms
Measured: Baseline, 12 weeks
Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores
This inventory monitors post-concussion symptoms
Measured: Baseline, 3 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Gould, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507214
- Sponsor's protocol ID
- IRB202600155
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
- ClinicalTrials.gov ID
- NCT07507214
- Acronym / sponsor ID
- IRB202600155
- Conditions
- Concussion, Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 2 Apr 2026 (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.
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits:
Previous studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.
Detailed description
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options.
The objective of this application is to treat female athletes with depression and concussion with the Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D) protocol.7 This is an innovative, one-day duration TMS treatment for depression. We propose to utilize tradition depression assessments, such as the Patient Health Questionnaire 9 (PHQ-9)8, as well as athlete-specific symptom inventories, including the Post-Concussion Symptom Scale (PCSS)9 and the Sport Mental Health Assessment Tool 1 (SMHAT-1)10 surveys to test our central hypothesis that female athletes with a history of concussion and depression will experience symptom improvement in depression inventories as well as athlete-specific symptom domains. We will assess associations between TMS treatment and depression through PHQ-9 and SMHAT-1 and associations between TMS treatment and concussion symptoms through PCSS.
Treatment Delivery
Once the subject completes the consent process, they will begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).The UF-World Equestrian center (WEC) pharmacy will dispense this medication prior to the study visit. The WEC pharmacy is located in the same physical building as the clinic where the treatment will take place. Patients will obtain their medication from the pharmacy prior to their treatment appointment. The medications will be consumed one hour (50-70 min) prior to the start of the first treatment under study staff supervision. After consuming the medication, the participant will begin baseline symptom inventory scores, including Sport Concussion Office Assessment Tool 6 (SCOAT6), Post-Concussion Symptom Scale (PCSS), Patient Health Questionnaire 9 (PHQ-9) and the Sport Mental Health Assessment Tool 1 (SMHAT-1).18 The treatment protocol consists of an AMPA device delivering accelerate theta-burst stimulation for a total of 600 pulses over 3 minute sessions.9 The treatment is repeated every 30 minutes (± 3 min) for a total of 20 sessions over 9.5 hours in a single day. The treatment will be performed by the research assistant or the research coordinator under PI supervision.
The Ampa TMS system was selected for this study as it uses anatomic locations to guide treatment targets, as opposed to other commercially available TMS systems that require FMRI imaging to create individual treatment plans. AMPS technology is FDA approved to be utilized in this manner.
Treatment parameters:
- 3 Hz x 600 pulses
- 90% of motor threshold for contralateral upper extremity
Symptom inventories will be recorded at weeks 3, 6, and 12 after the treatment session. The surveys will be collected through Redcap. Due to the nature of the surveys, the subjects will be called by a member of the research team during business hours so that if any subject is deemed positive for suicidality, the research team can immediately contact the PI and refer patient to treatment as stated in DSMB/DSMP. This may include a 911 welfare check. At the 12-week mark, the subjects will be called via zoom video call to complete the SCOAT6.
- Mez J, Daneshvar DH, Kiernan PT, et al. Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football. JAMA. 2017;318(4):360-370. doi:10.1001/jama.2017.8334
- Sandhu MRS, Schonwald A, Boyko M, et al. The association between female sex and depression following traumatic brain injury: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2025;168:105952. doi:10.1016/j.neubiorev.2024.105952
- McKee AC, Mez J, Abdolmohammadi B, et al. Neuropathologic and Clinical Findings in Young Contact Sport Athletes Exposed to Repetitive Head Impacts. JAMA Neurol. 2023;80(10):1037-1050. doi:10.1001/jamaneurol.2023.2907
- D'Lauro C, Jones ER, Swope LM, Anderson MN, Broglio S, Schmidt JD. Under-representation of female athletes in research informing influential concussion consensus and position statements: an evidence review and synthesis. Br J Sports Med. Published online July 18, 2022:bjsports-2021-105045. doi:10.1136/bjsports-2021-105045
- Meier TB, Giraldo-Chica M, España LY, et al. Resting-State fMRI Metrics in Acute Sport-Related Concussion and Their Association with Clinical Recovery: A Study from the NCAA-DOD CARE Consortium. J Neurotrauma. 2020;37(1):152-162. doi:10.1089/neu.2019.6471
- Milano BA, Palm S, Burke MJ, et al. Lesion network localization of functional and somatic symptoms. MedRxiv Prepr Serv Health Sci. Published online March 7, 2025:2025.03.06.25323494. doi:10.1101/2025.03.06.25323494
- Vaughn DA, Marino B, Engelbertson A, et al. Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D): An open-label case series. Transcranial Magn Stimul. 2025;5. doi:10.1016/j.transm.2025.100200
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613. doi:10.1046/j.1525-1497.2001.016009606.x
- Kontos AP, Elbin RJ, Schatz P, et al. A revised factor structure for the post-concussion symptom scale: baseline and postconcussion factors. Am J Sports Med. 2012;40(10):2375-2384. doi:10.1177/0363546512455400
- Gouttebarge V, Bindra A, Blauwet C, et al. International Olympic Committee (IOC) Sport Mental Health Assessment Tool 1 (SMHAT-1) and Sport Mental Health Recognition Tool 1 (SMHRT-1): towards better support of athletes' mental health. Br J Sports Med. 2021;55(1):30-37. doi:10.1136/bjsports-2020-102411
- Eagle SR, Womble MN, Elbin RJ, Pan R, Collins MW, Kontos AP. Concussion Symptom Cutoffs for Identification and Prognosis of Sports-Related Concussion: Role of Time Since Injury. Am J Sports Med. 2020;48(10):2544-2551. doi:10.1177/0363546520937291
- Broglio SP, Cantu RC, Gioia GA, et al. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014;49(2):245-265. doi:10.4085/1062-6050-49.1.07
- D'Lauro C, Jones ER, Swope LM, Anderson MN, Broglio S, Schmidt JD. Under-representation of female athletes in research informing influential concussion consensus and position statements: an evidence review and synthesis. Br J Sports Med. Published online July 18, 2022:bjsports-2021-105045. doi:10.1136/bjsports-2021-105045
- Musko PA, Demetriades AK. Are Sex Differences in Collegiate and High School Sports-Related Concussion Reflected in the Guidelines? A Scoping Review. Brain Sci. 2023;13(9):1310. doi:10.3390/brainsci13091310
- Harmon KG, Drezner J, Gammons M, et al. American Medical Society for Sports Medicine position statement: concussion in sport. Clin J Sport Med Off J Can Acad Sport Med. 2013;23(1):1-18. doi:10.1097/JSM.0b013e31827f5f93
- Rogers DL, Tanaka MJ, Cosgarea AJ, Ginsburg RD, Dreher GM. How Mental Health Affects Injury Risk and Outcomes in Athletes. Sports Health. 2024;16(2):222-229. doi:10.1177/19417381231179678
- Wolanin A, Hong E, Marks D, Panchoo K, Gross M. Prevalence of clinically elevated depressive symptoms in college athletes and differences by gender and sport. Br J Sports Med. 2016;50(3):167-171. doi:10.1136/bjsports-2015-095756
- Rogers DL, Tanaka MJ, Cosgarea AJ, Ginsburg RD, Dreher GM. How Mental Health Affects Injury Risk and Outcomes in Athletes. Sports Health. 2024;16(2):222-229. doi:10.1177/19417381231179678
- Reardon CL, Factor RM. Sport psychiatry: a systematic review of diagnosis and medical treatment of mental illness in athletes. Sports Med Auckl NZ. 2010;40(11):961-980. doi:10.2165/11536580-000000000-00000
- Mollica A, Greben R, Oriuwa C, Siddiqi SH, Burke MJ. Neuromodulation Treatments for Mild Traumatic Brain Injury and Post-concussive Symptoms. Curr Neurol Neurosci Rep. 2022;22(3):171-181. doi:10.1007/s11910-022-01183-w
- Patricios JS, Schneider KJ, Dvorak J, et al. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023;57(11):695-711. doi:10.1136/bjsports-2023-106898
- Coris EE, Moran B, Sneed K, et al. Stimulant Therapy Utilization for Neurocognitive Deficits in Mild Traumatic Brain Injury. Sports Health. 2022;14(4):538-548. doi:10.1177/19417381211031842
- Sharp T, Collins H. Mechanisms of SSRI Therapy and Discontinuation. Curr Top Behav Neurosci. 2024;66:21-47. doi:10.1007/7854_2023_452
- Billingham SAM, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013;13:104. doi:10.1186/1471-2288-13-104
- Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995;14(17):1933-1940. doi:10.1002/sim.4780141709
- Wennberg R, Hiploylee C, Tai P, Tator CH. Is Concussion a Risk Factor for Epilepsy? Can J Neurol Sci J Can Sci Neurol. 2018;45(3):275-282. doi:10.1017/cjn.2017.300
- Fitzgerald PB. An update on the clinical use of repetitive transcranial magnetic stimulation in the treatment of depression. J Affect Disord. 2020;276:90-103. doi:10.1016/j.jad.2020.06.067
- Mathias CW, Michael Furr R, Sheftall AH, Hill-Kapturczak N, Crum P, Dougherty DM. What's the harm in asking about suicidal ideation? Suicide Life Threat Behav. 2012 Jun;42(3):341-51.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female athletes with a history of concussion and depression | Experimental | Device: ONE-D TMS protocol and d-cycloserine (125 mg)Participants are treated with ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female athletes, both recreational and professional
- ages 18-65 years old
- Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present
- Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater
- Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks
Key exclusion criteria (11 listed)
- Pregnant or breast-feeding individuals
- History of seizures or epilepsy
- Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)
- Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)
- History of bipolar disorder
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 |
|---|---|---|
| ONE-D TMS protocol and d-cycloserine (125 mg)Begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg). | Device | Female athletes with a history of concussion and depression |
Primary outcome
Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores
Time frame: Baseline, 12 weeks
These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.
Sport Mental Health Assessment Tool 1 (SMHAT-1) depression symptom inventory scores
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks
These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.
2 secondary outcomes
Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms
Time frame: Baseline, 12 weeks
Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores
Time frame: Baseline, 3 weeks, 6 weeks, 12 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 18 Aug 2026.
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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.
Sara Gould, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ONE-D TMS protocol and d-cycloserine (125 mg) in people with Concussion and Depression, run by University of Florida 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sara Gould, MD (352-273-7381, gouldsj@ortho.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. 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 18 Aug 2026.