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

NCT04295720 | Terminated Results DMC FDA Device

• 1 other identifier: 1911180572
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemo-brain

Keywords

Chemo-brain; Post-Chemotherapy cognitive impairment; PCCI; Transcranial magnetic stimulation; TMS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Transcranial magnetic stimulation (TMS)

EXPERIMENTAL

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)

Interventions

Transcranial magnetic stimulation (TMS) DEVICE

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.

Transcranial magnetic stimulation (TMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Phillip H. Kuo, MD, PhD
• Organization: University of Arizona

pkuo@arizona.edu

520-626-1957

Study Officials

• Phillip Kuo, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12 participants with PCCI will be recruited to participate in this trial.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: March 5, 2021
• Primary Completion: January 3, 2022
• Study Completion: March 30, 2022
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-02

Locations

US (1)