Transcranial versus Direct Cortical Stimulation for Motor Evoked Potentials during Resection of Supratentorial Tumors under General Anesthesia (the TRANSEKT-Trial), a Randomized Controlled Study
Organizational Data
- DRKS-ID:
- DRKS00023256
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-10-29
- Last update in DRKS:
- 2021-07-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
TRANSEKT
URL of the study
No Entry
Brief summary in lay language
Monitoring of Motor-evoked potentials (MEP) is used to evaluate the motor function during removal of brain tumors under general anesthesia. These potentials are evoked either by transcranial stimulation or direct cortical stimulation of the cortex. The intraoperative deterioration of MEP predicts a deterioration in the postoperative motor function. Both stimulation modalities are used in the clinical intraoperative neurophysiological routine. The aim of the study is to compare the two methods with regard to the sensitivity and specificity of predicting postoperative paralysis during resection of supratentorially located tumors.
Brief summary in scientific language
The main aim of the trial is to gain knowledge about the sensitivity and specificity of each of transcranial and direct cortical stimulation in predicting postoperative deterioration of motor function. This is necessary to calculate the required number of patients in a confirmatory trial to test the superiority of one method over the other. The trial is also designed to study the effect of stimulation modality on the rate of postoperative paresis and extent of tumor resection. A further objective of the trial is to assess functional impairment using Karnofsky performance scale and the Barthel-index, as well as health related quality of life using EORTC QOL C30 and the simplified Beck Depression Inventory (BDI-S) in patients undergoing surgery for motor–eloquent brain tumors.
Health condition or problem studied
- ICD10:
- C71.0 - Cerebrum, except lobes and ventricles
- ICD10:
- C71.1 - Frontal lobe
- ICD10:
- C71.2 - Temporal lobe
- ICD10:
- C71.3 - Parietal lobe
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Resection of a supratentorial tumor under transcranial electrical stimulation for monitoring of motor evoked potentials
- Arm 2:
- Resection of a supratentorial tumor under direct cortical stimulation for monitoring of motor evoked potentials.
Endpoints
- Primary outcome:
- Sensitivity and specificity of direct cortical and transcranial stimulation, in terms of predicting motor findings upon discharge or 7 days after surgery.
- Secondary outcome:
- 1-Extent of tumor resection. 2-Clinical motor status 24 hours after surgery, on discharge (or 7 days after surgery) and after 3 months. 3-Barthel Index and Karnofsky performance Score, on discharge and after 3 months. 4-Self reported quality of life (EORTC QOL C30) and depressiveness (BDI-V) 3 months after surgery.
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Göttingen Göttingen
- University medical center Charité – Universitätsmedizin Berlin Berlin
- Medical center Universitätsmedizin Mainz Mainz
Recruitment period and number of participants
- Planned study start date:
- 2020-11-15
- Actual study start date:
- 2020-12-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- 1- Indication for surgical resection of a supratentorial tumor. 2- Suspected supratentorial glioma or metastasis in close vicinity to the corticospinal tract without Infiltration of the precentral gyrus, confirmed in a preoperative magnetic resonance imaging. 3- Missing or mild preoperative paresis (MRC grades 5 or 4) 4- Age => 18 and =< 80 years 5- Ability to give informed consent.
Exclusion Criteria
1- Age < 18 or > 80 years 2- Preoperative MRI is not available 3- Severe preoperative paralysis (MRC grades 1,2 or 3) 4- One of the stimulation modalities is not appropriate for intraoperative application according to the neurosurgeon.
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin GöttingenRobert-Koch-Strasse 4037075 GöttingenGermany
- Telephone:
- 0551-39-22711
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin GöttingenPD Dr. med Tammam AbboudRobert-Koch-Strasse 4037075 GöttingenGermany
- Telephone:
- 0551-39-65246
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsmedizin GöttingenPD Dr. med Tammam AbboudRobert-Koch-Strasse 4037075 GöttingenGermany
- Telephone:
- 0551-39-65246
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsmedizin GöttingenPD Dr. med Tammam AbboudRobert-Koch-Strasse 4037075 GöttingenGermany
- Telephone:
- 0551-39-65246
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin GöttingenRobert-Koch-Straße 4037099 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- +49-551-3969536
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-08-11
- Ethics committee number:
- 41/8/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-10-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- After the publication of the primary results, all data will be anonymised and published in an Open-Access-Repository.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry