Impact of nrTMS Therapy on the Progress of Neurorehabilitation

NCT ID: NCT03982329

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-07-31

Brief Summary

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Low-frequency navigated repetitive transcranial magnetic stimulation (nrTMS) of the non-damaged hemisphere to increase cortical excitability of the damaged hemisphere and to reduce the increased neuronal inhibition in patients suffering from new surgery-related paresis after brain tumor resection

Detailed Description

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Postoperative loss of motor function greatly impairs the patients' quality of life and life expectancy of patients with brain tumors is significant limited. Hence the reduction of time spent on neurorehabilitation is very important.

Inclusion of patients that underwent brain tumor resection with a surgery-related paresis of the upper extremity.

Randomized controlled and double blinded trial - 2/3 nrTMS, 1/3 sham. Fifteen minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days: nrTMS group or sham group. Thirty minutes physical therapy of the upper extremity in both groups.

MRI, nTMS motor mapping, assessments for motor status of upper extremity including Fugl-Meyer-Assessment (FMA), National Institution of Health Stroke Scale (NIHSS), Jebsen Taylor Hand Function Test (JTHFT), Nine Hole Peg Test (NHPT), and Karnofsky Performance Scale (KPS) postoperatively, after the 7th day of intervention and after 3 months.

Conditions

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Transcranial Magnetic Stimulation, Repetitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2/3 nrTMS, 1/3 sham
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nrTMS group

15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days

Group Type ACTIVE_COMPARATOR

navigated repetitive transcranial magnetic stimulation

Intervention Type DEVICE

physical therapy

Intervention Type PROCEDURE

sham group

15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days

Group Type SHAM_COMPARATOR

physical therapy

Intervention Type PROCEDURE

Interventions

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navigated repetitive transcranial magnetic stimulation

Intervention Type DEVICE

physical therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* New surgery-related paresis of upper extremity after brain tumor resection
* Written informed consent for participation

Exclusion Criteria

* Contraindications for MRI
* Contraindications for nrTMS
* Only biopsy instead of tumor resection
* Patients without preserved MEP response as measured by postoperative nTMS motor mapping
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Sandro M. Krieg

Attending Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandro M. Krieg, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, School of Medicine, TU Munich

Locations

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Department of Neurosurgery

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sandro M. Krieg, MD

Role: CONTACT

+498941402151

Sebastian Ille, MD

Role: CONTACT

+498941402151

Facility Contacts

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Sandro M Krieg, MD, MBA

Role: primary

References

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Ille S, Kelm A, Schroeder A, Albers LE, Negwer C, Butenschoen VM, Sollmann N, Picht T, Vajkoczy P, Meyer B, Krieg SM. Navigated repetitive transcranial magnetic stimulation improves the outcome of postsurgical paresis in glioma patients - A randomized, double-blinded trial. Brain Stimul. 2021 Jul-Aug;14(4):780-787. doi: 10.1016/j.brs.2021.04.026. Epub 2021 May 11.

Reference Type DERIVED
PMID: 33984536 (View on PubMed)

Other Identifiers

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12/15S

Identifier Type: -

Identifier Source: org_study_id

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