Clinical trial · Interventional
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
NCT00629265CI-TRIAL-00015965completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active NMES + Swallowing Exercise
- description
- Active Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.
- interventionNames
- Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
- type
- SHAM_COMPARATOR
- label
- Sham NMES + Swallowing Exercise
- description
- Sham (inactive) Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES) therapy will be paired concomitantly with repeated effortful sallowing exercises, for 60 swallows, 2 times per day, 6 days per week, for 12 weeks.
- interventionNames
- Device: Neurotech NT2000 Neuromuscular Electrical Stimulation (NMES)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ages 21+ * At least 3 months post-radiation therapy for head \& neck cancer * Treatment for their cancer can include chemotherapy. * Surgery for their cancer, if done, must meet these criteria: * diagnostic biopsy * less than ½ of oral tongue resected * less than ½ of tongue base resected * no floor of mouth muscles resected * less than 50% of any other part of the oral cavity, pharynx or larynx resected * no resection of hyoid * Neck dissection, unilateral or bilateral neck dissections may have been completed prior to or after radiation therapy. * Currently free of cancer, confirmed by head and neck exam within 2 months of beginning the study * MBS demonstrates penetration or aspiration on at least one swallow during the study (minimum PAS = 4) * The patient is free of any medical conditions that could limit the patient's ability to follow the protocol. * No history of any swallowing problems prior to the onset of head and neck cancer * Prior swallow therapy, if given to the patient, is neither an Inclusion nor Exclusion criteria Exclusion Criteria: * Inability to cooperate with the examination and treatment. * An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator) * Previous e-stim treatment to the head \& neck * Any current or previous neurological disease which may adversely affect swallowing. * History of oropharyngeal swallowing disorder prior to cancer. * History of pre-cancer oral intake that was limited due to a swallowing problem. * Previous neurosurgery on the brain that could compromise swallowing or ability to follow protocol. * Severe COPD (oxygen dependent). * Need for dilation of the upper esophageal sphincter or esophagus at time of entry. * Females who are currently pregnant will be excluded from participation. * Females of childbearing potential must have a negative pregnancy test and must be practicing a medically accepted means of contraception (including, but not limited to, condoms, diaphragms/caps, contraceptive pills, contraceptive rings/patches, intrauterine devices, hysterectomy or abstinence)
References
Publications (0)
Data not yet available
No reference posted for this study.