NCT03606161

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Aug 2018Dec 2027

First Submitted

Initial submission to the registry

July 20, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

9.4 years

First QC Date

July 20, 2018

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intervention adherence

    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.

    Up to 3 months

Other Outcomes (2)

  • Motor recovery

    Up to 3 months

  • Changes in cortical activity

    Baseline up to 3 months

Study Arms (1)

Supportive care (nrTMS)

EXPERIMENTAL

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

Other: Questionnaire AdministrationProcedure: Transcranial Magnetic Stimulation

Interventions

Ancillary studies

Supportive care (nrTMS)

Undergo nrTMS

Also known as: TMS
Supportive care (nrTMS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are taking any antipsychotic medications
  • Patients who have ever been diagnosed with bipolar disorder or schizophrenia
  • Patients with a history of stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Sarah Prinsloo

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

July 30, 2018

Study Start

August 23, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations