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Not yet recruitingPhase 2 / Phase 3

Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion

Optimized, Neuroplasticity Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "At the 12-week mark, the subjects will be called via zoom video call to complete the SCOAT6. 1."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ONE-D transcranial magnetic stimulation (TMS), a treatment that uses magnetic pulses to stimulate the brain. It is for female athletes ages 18–65 who have both a concussion and depression. Researchers want to learn whether it can help symptoms of both conditions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female athletes who play sports for fun or professionally.
  • Age 18–65.
  • A concussion confirmed by medical history, diagnosed at least 72 hours ago.
  • A score above 7 on the Post-Concussion Symptom Scale (PCSS), or more than 4 concussion symptoms.
  • A score of 10 or higher on the PHQ-9 depression survey, showing at least moderate depression.
  • Have taken or are taking an antidepressant by mouth for at least 6 weeks.

Who can't join

  • Pregnant or breastfeeding, or biologically male.
  • A history of seizures, epilepsy, or bipolar disorder.
  • Implanted devices, such as hearing implants, brain stimulators, clips or stents for weak blood vessels, pacemakers, or implanted defibrillators.
  • Taking medicines that can harm hearing, such as aminoglycoside antibiotics or cisplatin.
  • An allergy to d-cycloserine or another medical reason you cannot take it.
  • Other reasons the lead researcher decides the treatment would not be safe for you.
  • Unable to give informed consent because of language or other barriers. This means understanding the study and agreeing to join.
  • In jail or prison.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Study sites (1)

FL