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 range18 Years – 99 Years
SexALL
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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…
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