Brain Neoplasm
Conditions
Brief summary
This trial studies how well navigated repetitive transcranial magnetic stimulation works in improving motor rehabilitation in participants with brain tumors. Navigated repetitive transcranial magnetic stimulation may help improve patients' lost motor function after surgery.
Detailed description
PRIMARY OBJECTIVES: I. Determine feasibility of conducting 10 sessions of navigated repetitive transcranial magnetic stimulation (nrTMS) during the post-surgical rehabilitation time period. EXPLORATORY OBJECTIVES: I. Explore the effects of the nrTMS training program on motor recovery. II. Explore changes in cortical activity: electroencephalographic (EEG) activity including event-related potentials (ERPs) and motor evoked potentials (MEPs) will be assessed from baseline to end of treatment (EOT). OUTLINE: Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks. After completion of study, participants are followed up at 3 months.
Interventions
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURETranscranial Magnetic Stimulation
Undergo nrTMS
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with brain tumors associated with the motor cortex * Understand and read English, sign a written informed consent, and be willing to follow protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Motor impairment must be related to the surgical procedure or the tumor itself (in the opinion of the treating physician) * Patients who are within 7 days of brain tumor resection associated with the motor cortex * Eligibility for the nrTMS treatment will be based on motor ability and will be determined postoperatively by the surgeon
Exclusion criteria
* Patients who are taking any antipsychotic medications * Patients who have ever been diagnosed with bipolar disorder or schizophrenia * Patients with a history of stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention adherence | Up to 3 months | Will be defined as a participant as completing at least 70% of the (i.e., seven out of 10) treatment sessions. Feasibility will be defined as: 1) at least 70% of the participants adhere to the treatment. Patients will have to finish all 10 trains in each navigated repetitive transcranial magnetic stimulation (nrTMS) run in order to be considered complete; 2) at least 37% of the eligible patients (at a rate of approximately 3/8 per month) enroll in the study. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Prinsloo
M.D. Anderson Cancer Center
Outcome results
None listed