Chemo-brain
Conditions
Keywords
Chemo-brain, Post-Chemotherapy cognitive impairment, PCCI, Transcranial magnetic stimulation, TMS
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: 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.
Interventions
DEVICETranscranial 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.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
12 participants with PCCI will be recruited to participate in this trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory Testing | 14 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation (TMS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Neuropsychological testing | 130 total number of items recalled correctly |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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
Time frame: 14 days
Population: 1 participant was analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Memory Testing | 20 items recalled correctly |