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Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors

Primary Purpose

Brain Neoplasm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire Administration
Transcranial Magnetic Stimulation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (nrTMS)

Arm Description

Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2018
Last Updated
August 6, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03606161
Brief Title
Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors
Official Title
Feasibility of Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) to Augment the Effects of Motor Rehabilitation in Brain Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (nrTMS)
Arm Type
Experimental
Arm Description
Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
Undergo nrTMS
Primary Outcome Measure Information:
Title
Intervention adherence
Description
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.
Time Frame
Up to 3 months
Other Pre-specified Outcome Measures:
Title
Motor recovery
Description
Will conduct a paired sample t-test, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.
Time Frame
Up to 3 months
Title
Changes in cortical activity
Description
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).
Time Frame
Baseline up to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Prinsloo
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Navigated Repetitive Transcranial Magnetic Stimulation in Improving Motor Rehabilitation in Participants With Brain Tumors

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