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

NCT ID: NCT03606161

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (nrTMS)

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

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Undergo nrTMS

Interventions

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Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Transcranial Magnetic Stimulation

Undergo nrTMS

Intervention Type PROCEDURE

Other Intervention Names

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TMS

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Prinsloo

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2018-01476

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0269

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0269

Identifier Type: -

Identifier Source: org_study_id

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