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NCT Number: NCT03606161

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Brain Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

Transcranial magnetic stimulation

Procedure

Undergo nrTMS

Other names: TMS

Primary outcomes

  1. Intervention adherence

    Time frame: 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.

Other outcomes

  1. Motor recovery

    Time frame: Up to 3 months

    Will conduct a paired sample t-test, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.

  2. Changes in cortical activity

    Time frame: Baseline up to 3 months

    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).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) to Augment the Effects of Motor Rehabilitation in Brain Tumor Patients

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2018
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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