Trial Outcomes & Findings for Treatment of Post-Chemo Cognitive Impairment w/Transcranial Magnetic Stimulation (Chemobrain TMS) (NCT NCT04295720)

NCT ID: NCT04295720

Last Updated: 2023-03-03

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2023-03-03

Participant Flow

Participant milestones

Measure	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. The subjects will receive 10-sessions (1 session per day, M-F over 2 consecutive weeks). The treatment itself lasts approximately only 190 seconds.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Transcranial Magnetic Stimulation (TMS) n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Neuropsychological testing	130 total number of items recalled correctly STANDARD_DEVIATION NA • n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: 1 participant was analyzed.

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

Outcome measures

Measure	Transcranial Magnetic Stimulation (TMS) n=1 Participants Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors. This is an open label trial with only a treatment arm (no placebo group).
Memory Testing	20 items recalled correctly Standard Deviation NA Standard Deviation is not calculable for 1 participant

Adverse Events

Transcranial Magnetic Stimulation (TMS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Phillip H. Kuo, MD, PhD

University of Arizona

Phone: 520-626-1957

Email: pkuo@arizona.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place