Transcranial Magnetic Stimulation, RepetitiveNCT03982329
Impact of nrTMS Therapy on the Progress of Neurorehabilitation
A study testing navigated repetitive transcranial magnetic stimulation and physical therapy in people with Transcranial Magnetic Stimulation, Repetitive, run by Technical University of Munich at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcranial Magnetic Stimulation, Repetitive
- What is being tested?
- navigated repetitive transcranial magnetic stimulation and physical therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New surgery-related paresis of upper extremity after brain tumor resection
- Written informed consent for participation
Who cannot join
- Contraindications for MRI
- Contraindications for nrTMS
- Only biopsy instead of tumor resection
- Patients without preserved MEP response as measured by postoperative nTMS motor mapping
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery
Munich, Bavaria, 81675
Sandro M Krieg, MD, MBA, sandro.krieg@tum.de
About this study
Official title: Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
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
Read the detailed description
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.
- Being tested
- navigated repetitive transcranial magnetic stimulation, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated repetitive transcranial magnetic stimulationDevice
physical therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| nrTMS group | Active comparator | 15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days Receives: 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 Receives: Procedure: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fugl-Meyer Assessment (FMA)
Assessment upper extremity
Measured: Between first day of intervention and 3-months follow up
Secondary outcomes (4)
Nine Hole Peg Test (NHPT)
Fine motor skills upper extremity
Measured: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
National Institutes of Health Stroke Scale (NIHSS)
The scale measures neurological outcome; Total score is reported; Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe disability
Measured: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Jebsen Taylor Hand Function Test (JTHFT)
Functionality upper extremity
Measured: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Karnofsky Performance Status (KPS)
The scale measures general oncological outcome; the total score is reported; Scores on the KPS scale range from 0% to 100%, with higher scores indicating less disability and and better quality of life in cancer patients
Measured: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic Stimulation, RepetitiveStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2/3 nrTMS, 1/3 sham
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro M. Krieg, Technical University of Munich
- Investigators
- Sandro M. Krieg, MD, Principal investigator, Department of Neurosurgery, School of Medicine, TU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982329
- Sponsor's protocol ID
- 12/15S
- Status last verified
- Jun 2019
- First submitted
- 17 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33984536
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT03982329
- Acronym / sponsor ID
- 12/15S
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2/3 nrTMS, 1/3 sham
| Arm | Type | Receives |
|---|---|---|
| nrTMS group | Active comparator | Device: navigated repetitive transcranial magnetic stimulation, Procedure: physical therapy15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days |
| sham group | Sham comparator | Procedure: physical therapy15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New surgery-related paresis of upper extremity after brain tumor resection
- Written informed consent for participation
Key exclusion criteria (4 listed)
- Contraindications for MRI
- Contraindications for nrTMS
- Only biopsy instead of tumor resection
- Patients without preserved MEP response as measured by postoperative nTMS motor mapping
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navigated repetitive transcranial magnetic stimulation | Device | nrTMS group |
| physical therapy | Procedure or surgery | nrTMS group, sham group |
Primary outcome
Change of Fugl-Meyer Assessment (FMA)
Time frame: Between first day of intervention and 3-months follow up
Assessment upper extremity
4 secondary outcomes
Nine Hole Peg Test (NHPT)
Time frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
National Institutes of Health Stroke Scale (NIHSS)
Time frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Karnofsky Performance Status (KPS)
Time frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 33984536Ille 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro M. Krieg, MD principal investigator
Department of Neurosurgery, School of Medicine, TU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navigated repetitive transcranial magnetic stimulation and physical therapy in people with Transcranial Magnetic Stimulation, Repetitive, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro M. Krieg, MD (+498941402151, sandro.krieg@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fugl-Meyer Assessment (FMA) (time frame: Between first day of intervention and 3-months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.