Impact of nrTMS Therapy on the Progress of Neurorehabilitation

NCT03982329 | Unknown DMC

• 1 other identifier: 12/15S
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transcranial Magnetic Stimulation, Repetitive

Outcome Measures

Primary Outcomes (1)

• Change of Fugl-Meyer Assessment (FMA)

  Assessment upper extremity

  Between first day of intervention and 3-months follow up

Secondary Outcomes (4)

• Nine Hole Peg Test (NHPT)

  First day of intervention = postoperatively, after the 7th day of intervention and after 3 months

• National Institutes of Health Stroke Scale (NIHSS)

  First day of intervention = postoperatively, after the 7th day of intervention and after 3 months

• Jebsen Taylor Hand Function Test (JTHFT)

  First day of intervention = postoperatively, after the 7th day of intervention and after 3 months

• Karnofsky Performance Status (KPS)

  First day of intervention = postoperatively, after the 7th day of intervention and after 3 months

Study Arms (2)

nrTMS group

ACTIVE COMPARATOR

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

Device: navigated repetitive transcranial magnetic stimulation; Procedure: physical therapy

sham group

SHAM COMPARATOR

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

Procedure: physical therapy

Interventions

navigated repetitive transcranial magnetic stimulation DEVICE

nrTMS group

physical therapy PROCEDURE

nrTMS group; sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Neurosurgery

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 33984536 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sandro M. Krieg, MD

  Department of Neurosurgery, School of Medicine, TU Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro M. Krieg, MD

CONTACT

+498941402151; sandro.krieg@tum.de

Sebastian Ille, MD

CONTACT

+498941402151; sebastian.ille@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neurosurgeon

Model Details: 2/3 nrTMS, 1/3 sham

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: June 11, 2019
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)