Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT04966520
Eligibility Criteria:
Inclusion Criteria:
* Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy
* Received cytotoxic chemotherapy as a part of their therapy for cancer and at least one month has passed since the final cytotoxic chemotherapy treatment
* ≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy
* Patients must report subjective symptoms of "chemo-brain" (memory loss, difficulty with concentration, word-finding difficulties) with a FACT-Cog perceived cognitive impairment score \< 60
* Ability to sign informed consent and comply with study procedures
Exclusion Criteria:
* Patients with a recurrence of cancer or those with current metastatic disease
* Patients with a history or current diagnosis of brain metastasis
* Patients with a history or current diagnosis of a primary brain tumor
* Patients with a history of brain surgery or brain radiation
* Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy
* Patients who cannot produce or request adequate medical record documentation to ensure they meet inclusion and exclusion criteria
* Women who are currently pregnant
* History of childhood cancer or receipt of chemotherapy in childhood (\<age 18). Developmental insult to the PFC, can be associated with long-term, durable and sometime debilitating cognitive deficits. Hence, we avoid any cognitive confounds that maybe related to this issue.
* Patients with a weight over 250 lbs., as these patients would not fit in the MRI scanner used in the protocol
* Patients who require benzodiazepines for MRI due to claustrophobic anxiety
* Patients with chest wall tissue expanders or other retained 7 Tesla MRI-incompatible metal. Any other specific contraindication to TMS or MRI not already listed above, including:
* (a) any implanted device in the head, neck or upper body (e.g. cochlear implant, cranial or other electrodes, pacemaker or defibrillator, medication pump, stent, aneurysm clip, etc.)
* (b) personal history of seizures or epilepsy, personal history of multiple concussions or unexplained loss of consciousness. This will be determined by physician judgement
* History of adverse reaction to previous TMS or MRI exposure
* Active substance use disorder in the past 6 months, excluding tobacco use disorder, as diagnosed by study physicians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04966520
Study Brief:
Protocol Section:
NCT04966520