Impact of nrTMS Therapy on the Progress of Neurorehabilitation
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|ClinicalTrials.gov Identifier: NCT03982329|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Transcranial Magnetic Stimulation, Repetitive||Device: navigated repetitive transcranial magnetic stimulation Procedure: physical therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2/3 nrTMS, 1/3 sham|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
Active Comparator: nrTMS group
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 Comparator: sham group
15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days
Procedure: physical therapy
- Change of Fugl-Meyer Assessment (FMA) [ Time Frame: Between first day of intervention and 3-months follow up ]Assessment upper extremity
- Nine Hole Peg Test (NHPT) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]Fine motor skills upper extremity
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]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
- Jebsen Taylor Hand Function Test (JTHFT) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]Functionality upper extremity
- Karnofsky Performance Status (KPS) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]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
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): NCT03982329
|Contact: Sandro M. Krieg, MDemail@example.com|
|Contact: Sebastian Ille, MDfirstname.lastname@example.org|
|Department of Neurosurgery||Recruiting|
|Munich, Bavaria, Germany, 81675|
|Contact: Sandro M Krieg, MD, MBA email@example.com|
|Principal Investigator:||Sandro M. Krieg, MD||Department of Neurosurgery, School of Medicine, TU Munich|