Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy (NCT04966520) | Clinical Trial Compass
CompletedNot Applicable
Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy
United States15 participantsStarted 2021-06-01
Plain-language summary
This project is aimed at the discovery of neuro-modulation techniques that may alleviate chemotherapy induced cognitive deficits (CICD), especially in executive (higher-order) cognitive function (EF).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol
Timeframe: 1.5 months
2
Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol