Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

— DPS in ALS  

Official title:

Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS)In Participants With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938495
• Other study ID #: 2013P001504
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: April 2017

Study information

• Verified date: March 2023
• Source: Barrow Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function.

The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.

The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.

Description:

The study is a randomized controlled study to compare standard of care (control) to DPS (diaphragm stimulator named The NeuRx® Diaphragm Pacing System™). Although it remains uncertain if DPS is efficacious for the ALS subject, given the preliminary studies performed by the device manufacturer, it has received FDA humanitarian device exemption (HDE) approval as a humanitarian use device (HUD). This study will utilize a 2:1 randomization schedule such that eligible ALS subjects will have a 2/3 chance of receiving DPS and 1/3 chance of standard of care (control) treatment.

The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Under general anesthesia, the intramuscular electrodes are laparoscopically implanted in the diaphragm. The ends of the implanted electrodes are tunneled subcutaneously to an exit site on the chest or abdominal wall and connected to an external stimulator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age 21 years or older.

2. Sporadic or familial ALS diagnosed as definite, probable or possible ALS as defined by revised El Escorial criteria.

3. Evidence of hypoventilation at Screening with at least one of the following:

1. Maximal static inspiratory pressure (MIP) <60 cm H20.

2. Upright or supine forced vital capacity (FVC) <50% predicted for gender, age, and height.

4. A phrenic nerve potential should be recordable bilaterally.

5. Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to randomization (riluzole-naïve subjects are permitted in the study).

6. Capable of providing informed consent and following trial procedures.

7. Geographically accessible to the site.

8. Negative urine pregnancy test at Screening in women of child bearing potential (WOCBP). (Women who are post-menopausal or who have had a hysterectomy are deemed not of child bearing potential).

9. Women of child bearing potential must use an adequate form of contraception:

abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for = 3 months, barrier method in conjunction with spermicide, or another adequate method.

Exclusion Criteria:

1. Upright forced vital capacity (FVC) = 45% of predicted for gender, age, and height.

2. Any prior use of non-invasive ventilation (NIV) outside of sleep (nighttime or naps).

3. Any pulmonary or cardiac disorder or other medical disorder that would be a contraindication for general anesthesia or DPS hardware implantation in the chest.

4. Implanted electrical device such as a pacemaker or cardiac defibrillator.

5. Known diaphragm abnormality such as hiatal hernia or para-esophageal hernia of abdominal contents into the thoracic cavity.

6. Participation in another treatment research study for people with ALS.

7. Exposure to any other agent currently under investigation for the treatment of people with ALS (off-label use or investigational) within 30 days of the Screening Visit.

8. Clinically significant history of unstable or severe cardiac, oncologic, hepatic, psychiatric, renal disease, or other medically significant illness.

9. Pregnant women or women currently breastfeeding.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• NeuRx® Diaphragm Pacing System™ (DPS)
The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Pictures of the device are provided in the Clinician's Manual for the NeuRx® DPS procedure and technique guide from the manufacture Synapse Biomedical, Inc. Under general anesthesia, the intramuscular electrodes are laparoscopically implanted in the diaphragm. The ends of the implanted electrodes are tunneled subcutaneously to an exit site on the chest or abdominal wall and connected to an external stimulator.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Carolinas Health Care	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Henry Ford Health Systems	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Florida, Jacksonville	Jacksonville	Florida
United States	Neurology Associates P.C.	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Hospital for Special Care	New Britain	Connecticut
United States	Hospital for Special Surgery	New York	New York
United States	Drexel University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Providence ALS Center	Portland	Oregon
United States	St Louis University	Saint Louis	Missouri
United States	University of Texas	San Antonio	Texas
United States	California Pacific Medical Center	San Diego	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Barrow Neurological Institute	ALS Association, Muscular Dystrophy Association, Synapse Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Subjects will be assessed on a monthly basis for an 18 month period.
Secondary	quality of life		Subjects will be assessed on a monthly basis for an 18 month period.

External Links

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