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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01476 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0269 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (nrTMS) | Experimental | Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention adherence | 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. | Up to 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Motor recovery | Will conduct a paired sample t-test, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point. | Up to 3 months |
| Changes in cortical activity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Transcranial Magnetic Stimulation |
| Procedure |
Undergo nrTMS |
|
|
Will include pre and post comparisons of the electroencephalogram, via event related potential (ERP) analysis. Baseline LORETA analyses will include global differences in cortical activation as well as site-specific dominant frequencies for each patient. Will observe baseline differences in amplitude, power, and relative power for delta, theta, alpha, low beta, high beta, gamma, theta/beta ratio, and alpha/beta ratios for each patient. ERP analysis will compare amplitudes in the surgical hemisphere and the normal hemisphere via an asymmetry index which will be computed for each pair of homologous electrodes and in each condition: AI = (surgical ERP) - (healthy ERP on the homologous site)/the peak ERP at any site. To assess inter-hemispheric imbalances in cortical excitability, will determine differences in the nrTMS group and the Human Brain Index Reference Database (HBIRD).
| Baseline up to 3 months |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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