A Phase 2/3 interventional study of ONE-D TMS protocol and d-cycloserine (125 mg) in Concussion and Depression, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Florida · Phase 2/3, Interventional, and Treatment
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.
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:
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 35 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: 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).
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.
Time frame: 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.
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks
Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms
This inventory monitors concussion symptoms
Time frame: Baseline, 12 weeks
Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores
This inventory monitors post-concussion symptoms
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks
Start is estimated for Sep 2026; primary completion for Jun 2028, 21 months later.
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