Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients

NCT ID: NCT01956175

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to evaluate whether electrical pharyngeal stimulation in addition to standard care can enhance short-term swallow recovery in tracheostomized dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham treatment plus standard care.

Detailed Description

Readiness for decannulation is assessed after three days of either real or sham electrical pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is an open-label follow-up treatment phase, in which every patient in the sham treatment arm gets another three days of real electrical pharyngeal stimulation to not deprive any patient of a potentially beneficial treatment.

Conditions

Stroke; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Electrical pharyngeal stimulation

Electrical pharyngeal stimulation once daily for 10 minutes on three consecutive days.

Group Type: EXPERIMENTAL

Electrical pharyngeal stimulation

Intervention Type: DEVICE

Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.

Sham stimulation

Sham stimulation once daily for 10 minutes on three consecutive days. If the subject cannot be decannulated after three days of sham stimulation, another three days of real electrical pharyngeal stimulation will be delivered.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.

Interventions

Electrical pharyngeal stimulation

Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.

Intervention Type: DEVICE

Sham stimulation

The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.

Intervention Type: DEVICE

Other Intervention Names

Phagenesis Limited, UK.; EPS1 device

Eligibility Criteria

Inclusion Criteria

• severe dysphagia due to acute stroke
• completely weaned from mechanical ventilation
• impossibility of decannulation because of severe dysphagia with ongoing aspiration

Exclusion Criteria

• preexisting dysphagia
• comorbidities that can possibly cause dysphagia
• psychiatric comorbidities
• pacemaker or other implanted electronic devices

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Dziewas, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Muenster

Locations

Department of Neurology, University of Muenster

Münster, Muenster, Germany

Countries

Germany

References

Warnecke T, Suntrup S, Teismann IK, Hamacher C, Oelenberg S, Dziewas R. Standardized endoscopic swallowing evaluation for tracheostomy decannulation in critically ill neurologic patients. Crit Care Med. 2013 Jul;41(7):1728-32. doi: 10.1097/CCM.0b013e31828a4626.

Reference Type: BACKGROUND

PMID: 23774336 (View on PubMed)

Fraser C, Power M, Hamdy S, Rothwell J, Hobday D, Hollander I, Tyrell P, Hobson A, Williams S, Thompson D. Driving plasticity in human adult motor cortex is associated with improved motor function after brain injury. Neuron. 2002 May 30;34(5):831-40. doi: 10.1016/s0896-6273(02)00705-5.

Reference Type: BACKGROUND

PMID: 12062028 (View on PubMed)

Suntrup S, Marian T, Schroder JB, Suttrup I, Muhle P, Oelenberg S, Hamacher C, Minnerup J, Warnecke T, Dziewas R. Electrical pharyngeal stimulation for dysphagia treatment in tracheotomized stroke patients: a randomized controlled trial. Intensive Care Med. 2015 Sep;41(9):1629-37. doi: 10.1007/s00134-015-3897-8. Epub 2015 Jun 13.

Reference Type: DERIVED

PMID: 26077087 (View on PubMed)

Other Identifiers

2011-580

Identifier Type: -

Identifier Source: org_study_id