search
Back to results

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

Primary Purpose

Chemo-brain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemo-brain focused on measuring Chemo-brain, Post-Chemotherapy cognitive impairment, PCCI, Transcranial magnetic stimulation, TMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Taking medication for seizures or that could lower seizure threshold if withdrawn.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.

Sites / Locations

  • University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial magnetic stimulation (TMS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 27, 2020
Last Updated
February 28, 2023
Sponsor
University of Arizona
search

1. Study Identification

Unique Protocol Identification Number
NCT04295720
Brief Title
Treatment of Post-Chemo Cognitive Impairment w/Transcranial Magnetic Stimulation (Chemobrain TMS)
Official Title
Treatment of Post-Chemotherapy Cognitive Impairment With Transcranial Magnetic Stimulation (Chemobrain TMS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to the risk of COVID-19 variants to our subject base of cancer patients
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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. use TMS to stimulate the target region of the brain. 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. perform neuropsychological tasks baseline and post-TMS to study if performance is improved following stimulation of the target brain region. collect data from completing Frailty assessments, baseline and post-TMS. study the short-term and long-term treatment effects. collect subject's daily activity and sleep/wake patterns from watch style device (http://www.actigraphy.com/solutions/actiwatch/actiwatch-plus-specifications.html). perform behavioral assessments, baseline and post-TMS, to study whether there are measurable changes following stimulation of the target brain region.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemo-brain
Keywords
Chemo-brain, Post-Chemotherapy cognitive impairment, PCCI, Transcranial magnetic stimulation, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
12 participants with PCCI will be recruited to participate in this trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial magnetic stimulation (TMS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Memory Testing
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Kuo, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs