Treatment of Post-Chemo Cognitive Impairment w/Transcranial Magnetic Stimulation (Chemobrain TMS)

Treatment of Post-Chemotherapy Cognitive Impairment With Transcranial Magnetic Stimulation (Chemobrain TMS)

In this pilot study, the investigators propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.

Study Overview

• Status: Terminated
• Conditions: Chemo-brain
• Intervention / Treatment: Device: Transcranial magnetic stimulation (TMS)

Detailed Description

Transcranial magnetic stimulation (TMS) is a safe and non-invasive brain stimulation technique. It uses a magnetic coil to stimulate brain tissue painlessly using only a magnet (no electrodes or electrical wires) in a procedure that does not involve any surgery or sedation. TMS is currently FDA approved to treat depression and migraines. Although this technology is applicable to many other brain conditions as well, it has not been systematically examined in individuals with "Chemo-brain". Chemo-brain or Post-Chemotherapy Cognitive Impairment (PCCI) is defined as cognitive changes including impairment of memory, learning, concentration, reasoning, executive function, attention and visuo visio-spatial skills that occur during or after chemotherapy treatment.

In this study, investigators will:

1. use high-resolution magnetic resonance imaging (MRI) of individuals' brains to determine precisely where to place the TMS magnetic coil in order to stimulate the target brain region based off their unique brain structure.
2. use TMS to stimulate the target region of the brain.
3. take high-resolution MRI pictures of the brain both baseline and post-TMS to study whether the brain activity of the target region changes as a result of the TMS stimulation.
4. perform neuropsychological tasks baseline and post-TMS to study if performance is improved following stimulation of the target brain region.
5. collect data from completing Frailty assessments, baseline and post-TMS.
6. study the short-term and long-term treatment effects.
7. collect subject's daily activity and sleep/wake patterns from watch style device (http://www.actigraphy.com/solutions/actiwatch/actiwatch-plus-specifications.html).
8. perform behavioral assessments, baseline and post-TMS, to study whether there are measurable changes following stimulation of the target brain region.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (>=18).
• PCCI diagnosis (see information below).
• Right Handed (We will not enroll left-handed dominant people because they tend to have more symmetric brain function and thus targeting the left frontal region may not be as effective.)
• English speaking.
• Cancer treatment completed and considered curative with the exception of endocrine therapy after chemotherapy.
• Able to attend daily intervention (Monday-Friday) for 2 weeks.
• Not enrolled in another interventional study within 6 months prior to beginning this study.

Exclusion Criteria:

• Pregnancy or thinking of becoming pregnant.
• Undergoing active treatment for cancer.
• Routine contraindications for MRI (including incompatible medical implants or metal fragments in the body at risk for migration or heating with application of the magnetic field) including severe claustrophobia.
• History of brain metastasis or other brain tumor.
• History of stroke or traumatic brain injury.
• Frequent or severe headaches.
• Cognitive or mood disorder prior to chemotherapy (i.e. dementia or depression).
• History of epilepsy, or other seizure disorders.
• History mental health disorders, such as substance misuse, bipolar disorder or psychosis.
• Taking medication for seizures or that could lower seizure threshold if withdrawn.
• Inability to complete neuropsychological testing.
• Prior treatment with rTMS. We will enroll subjects without prior experience with rTMS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transcranial magnetic stimulation (TMS); We propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.

Device: Transcranial magnetic stimulation (TMS); Subjects will undergo testing at baseline prior to TMS treatments and once more at the end of the 2-week intervention.After the conclusion of baseline data acquisition, the research team will analyze each participant's unique structural and functional connectivity patterns to determine stimulation site for TMS in future study sessions. The subjects will receive 10-sessions (1 session per day, M-F over 2 consecutive weeks). The treatment itself lasts approximately only 190 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory Testing	Efficacy measures will include baseline and post-rTMS neuropsychological testing. The Outcome Measure is the difference between the pre and post scores of the following Neuropsychological tests. The score from each test was added together to come up with a single value. A higher score indicates better performance. Minimum is score of 0 and maximum is not applicable (a timed test). The Neuropsychological tests we analyzed: Forward Digit Span Backward Digit Span Rey Auditory Verbal Learning Test Verbal Fluency Task Stroop Color-Word Interference Task	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test for improved brain functional connectivity on fMRI.	Take high-resolution MRI pictures of the brain both baseline and post-TMS to study whether the brain activity of the target region changes as a result of the TMS stimulation.	Two weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Phillip Kuo, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial magnetic stimulation; Chemo-brain; TMS; Post-Chemotherapy cognitive impairment; PCCI
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neurocognitive Disorders; Cognition Disorders; Drug-Related Side Effects and Adverse Reactions; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment
• Other Study ID Numbers: 1911180572

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes