Impact of nrTMS Therapy on the Progress of Neurorehabilitation
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 05/16/2019 |
| Estimated Enrollment Submitted: | 06/09/2019 |
| First Posted: | 06/10/2019 |
| Last Update Submitted: | 06/09/2019 |
| Last Update Posted: | 06/10/2019 |
| Actual Study Start Date: | 05/31/2015 |
| Estimated Primary Completion Date: | 05/31/2019 |
| Estimated Study Completion Date: | 06/30/2019 |
Condition or disease
Intervention/treatment
Device: nrTMS group
Procedure: physical therapy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: nrTMS group 15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days | Device: nrTMS group |
| Sham Comparator: sham group 15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change of Fugl-Meyer Assessment (FMA) [Between first day of intervention and 3-months follow up]
Secondary Outcome Measures
1. Nine Hole Peg Test (NHPT) [First day of intervention = postoperatively, after the 7th day of intervention and after 3 months]
2. National Institutes of Health Stroke Scale (NIHSS) [First day of intervention = postoperatively, after the 7th day of intervention and after 3 months]
3. Jebsen Taylor Hand Function Test (JTHFT) [First day of intervention = postoperatively, after the 7th day of intervention and after 3 months]
4. Karnofsky Performance Status (KPS) [First day of intervention = postoperatively, after the 7th day of intervention and after 3 months]
