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NCT05375669: CCCV
The Effect of Increasing Current or Pulse Duration on Patient Movement and Intraoperative Transcranial Electric Stimulation Motor Evoked Potential Amplitude
NA trial testing ISIS IOM System in Surgery in 31 participants. Completed in 1 November 2024.
1 November 2024
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 10 August 2022 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- ISIS IOM System
Conditions studied
- Surgery — all drugs for Surgery →
Sponsor
Insel Gruppe AG, University Hospital Bern
Who can join
18 and older, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Transcranial electric stimulation (TES) motor evoked potential (MEP) monitoring is standard during surgery risking motor system injury. The stimuli are typically 5-pulse trains with a 4 ms interstimulus interval (ISI). The pulse duration (D) is often set to 50 or 500 µs. Both are effective, but setting D to the chronaxie would be physiologically optimal and limited data suggest that mean MEP chronaxie may be near 200 µs. When necessary, one can obtain larger MEPs by increasing current (I) or D to increase stimulus charge (Q = I × D). However, this also increases patient movement that can interfere with surgery and reduce MEP acquisition frequency. The main research question is whether increasing current or pulse duration when applying intraoperative neuromonitoring produces less patient movement during surgery. As such, the IOM ISIS System will be employed for neuromonitoring and an accelerometer will be used to quantify patient movement. The constant-current TES stimulators will be used in this study with a high-precision oscilloscope. Total intravenous anesthesia (TIVA), surgery and TES MEP monitoring will proceed routinely without modification and normally involves acquiring many MEPs over several hours. The only departure from standard care will be the placement of two small accelerometers and a brief MEP sequence before skin incision to determine chronaxie and compare the effect of an equivalent increase of I or D on MEP amplitude and movement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05375669
- Europe PMC full search
- ASCO Meeting Library
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Other Insel Gruppe AG, University Hospital Bern trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05375669 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 1 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05375669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing