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Neuro-modulation

Neuromodulation for Chemotherapy-Induced Cognitive Impairment

N/A
Waitlist Available
Led By Sneha Phadke, DO
Research Sponsored by Sneha Phadke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy
≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 months
Awards & highlights

Study Summary

This trial is testing new ways to help people with chemotherapy-induced cognitive deficits, specifically in executive function.

Who is the study for?
This trial is for adults who've had non-metastatic cancer, finished curative therapy including chemotherapy at least a month ago, and are experiencing 'chemo-brain' symptoms like memory issues or trouble concentrating. They must be able to consent and follow study procedures but can't join if they're pregnant, over 250 lbs., need benzodiazepines for MRI anxiety, have metal implants incompatible with MRI/TMS, history of seizures/epilepsy/concussions, active substance use (except tobacco), brain metastasis/tumor history or ongoing metastatic disease.Check my eligibility
What is being tested?
The trial tests accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) as a potential treatment to improve cognitive functions affected by chemotherapy. It focuses on executive functions such as decision-making and problem-solving in those reporting 'chemo-brain'.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the scalp, headache, lightheadedness or dizziness during iTBS sessions. There's also a small risk of seizure although this is rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had cancer that did not spread and have completed all treatments aimed at curing it.
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I was 18 or older when diagnosed with cancer and received chemotherapy.
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I finished my chemotherapy over a month ago.
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I experience memory and concentration issues due to chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean changes in brain metabolite concentrations between pre and post application of iTBS treatment protocol
Mean changes in executive cognitive function between pre and post application of iTBS treatment protocol

Trial Design

1Treatment groups
Experimental Treatment
Group I: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or shamExperimental Treatment1 Intervention
Patients will participate in the prospective longitudinal research protocol over a period of 1.5 months. Treatment will include 8 visits of either accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or iTBS sham stimulation. Patients will be informed that iTBS sham stimulations will be part of the protocol (but will be blind to when treatment/sham will be administered).

Find a Location

Who is running the clinical trial?

Sneha PhadkeLead Sponsor
Kanchna RamchandranLead Sponsor
American Cancer Society-Holden Comprehensive Cancer SocietyUNKNOWN

Media Library

Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) (Neuro-modulation) Clinical Trial Eligibility Overview. Trial Name: NCT04966520 — N/A
Cancer Research Study Groups: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or sham
Cancer Clinical Trial 2023: Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) Highlights & Side Effects. Trial Name: NCT04966520 — N/A
Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) (Neuro-modulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966520 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to be included in this medical research?

"To be eligible, potential participants should both have cancer and be within the 18-99 year old range. This experiment is looking to recruit approximately 15 individuals."

Answered by AI

Do participants of this medical experiment have to be above a certain age?

"The medical trial's inclusionary criteria outlines that potential participants must be between 18 to 99 years of age. Separately, there are 86 studies for minors and 977 trials designed for seniors."

Answered by AI

What is the ultimate participant capacity of this medical trial?

"Yes, according to clinicaltrials.gov, this study is actively enlisting volunteers and has been since June 1st 2021 with a most recent update on September 1st 2022. Fifteen patients are needed for the research at one centre."

Answered by AI

Does this research program have any vacancies for participants?

"The specified clinical trial is currently open for enrolment, as indicated on the website of ClinicalTrials.gov. This research was initiated on June 1st 2021 and its details were most recently updated on September 1st 2022."

Answered by AI
~4 spots leftby Mar 2025