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

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ClinicalTrials.gov Identifier: NCT03606161
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Other: Questionnaire Administration Procedure: Transcranial Magnetic Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) to Augment the Effects of Motor Rehabilitation in Brain Tumor Patients
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : August 23, 2021
Estimated Study Completion Date : August 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive care (nrTMS)
Between 1-7 days after standard of care surgery, participants undergo 10 nrTMS sessions over 30 minutes each over 3 weeks.
Other: Questionnaire Administration
Ancillary studies

Procedure: Transcranial Magnetic Stimulation
Undergo nrTMS
Other Name: TMS




Primary Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606161


Contacts
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Contact: Sarah Prinsloo 713-745-2668 sprinsloo@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarah Prinsloo    713-745-2668      
Principal Investigator: Sarah Prinsloo         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sarah Prinsloo M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03606161     History of Changes
Other Study ID Numbers: 2018-0269
NCI-2018-01476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0269 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases