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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Brain Neoplasm

Treatments: Procedure: Transcranial Magnetic Stimulation; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03606161

NCI-2018-01476 (Registry Identifier)

2018-0269 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Supportive care (nrTMS)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Transcranial Magnetic Stimulation