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

Not Applicable

Active, not recruiting

• Conditions: Brain Neoplasm
• Interventions: Other: Questionnaire Administration; Procedure: Transcranial Magnetic Stimulation

• Registration Number: NCT03606161
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Study Start: 2018-08-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (nrTMS)	Questionnaire Administration	Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.
Supportive care (nrTMS)	Transcranial Magnetic Stimulation	Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States