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Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB) (VNS-REHAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131960
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Results First Posted : June 14, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
ResearchPoint Global
Information provided by (Responsible Party):
MicroTransponder Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cerebrovascular Stroke
Upper Extremity Paresis
Interventions Device: Paired Vagus Nerve Stimulation
Other: Rehabilitation
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Period Title: Overall Study
Started 53 [1] 55 [2]
Completed 53 54
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
1 participant missed the day one visit (V5) but remained in the study and returned for the day 90 assessment (V7).
[2]
1 discontinued treatment due to adverse event and inability to tolerate rehabilitation.
Arm/Group Title VNS + Rehabilitation (1) Control VNS Total
Hide Arm/Group Description

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Total of all reporting groups
Overall Number of Baseline Participants 53 55 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  56.6%
35
  63.6%
65
  60.2%
>=65 years
23
  43.4%
20
  36.4%
43
  39.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 55 participants 108 participants
59.1  (10.2) 61.1  (9.2) 60.1  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
Female
19
  35.8%
19
  34.5%
38
  35.2%
Male
34
  64.2%
36
  65.5%
70
  64.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.9%
Asian
1
   1.9%
2
   3.6%
3
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  17.0%
9
  16.4%
18
  16.7%
White
42
  79.2%
42
  76.4%
84
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.9%
1
   1.8%
2
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
United States 36 38 74
United Kingdom 17 17 34
FMA-UE Baseline Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 53 participants 55 participants 108 participants
34.4  (8.2) 35.7  (7.8) 35.1  (8.0)
[1]
Measure Description: The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The study allowed entry on the FMA-UE between 20 and 50.
WMFT Baseline Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 53 participants 55 participants 108 participants
2.71  (0.70) 2.83  (0.65) 2.76  (0.67)
[1]
Measure Description: The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal).
1.Primary Outcome
Title Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
Hide Description The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at 1-day after 6-weeks of therapy compared to baseline (Difference in average change in FM-A from baseline [V4] to one day after therapy [V5]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Time Frame V5, One day after 6-weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description:

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (4.4) 2.4  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS + Rehabilitation (1), Control VNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
Hide Description The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for change in average score at 90-days after 6-weeks of therapy (change in average FMA-UE from baseline [V4] to 90 days after therapy [V7]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Time Frame V7, 90 days after 6-weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description:

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (6.0) 2.8  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS + Rehabilitation (1), Control VNS
Comments ANCOVA
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response
Hide Description The Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response is the percent of patients with a 6 point or greater improvement on the (FMA-UE). The percent of patients with the 6-point change is calculated at 90-days after 6-weeks of therapy compared to baseline (V4). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Time Frame V7, 90 days after 6-weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description:

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Overall Number of Participants Analyzed 53 55
Measure Type: Count of Participants
Unit of Measure: Participants
25
  47.2%
13
  23.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS + Rehabilitation (1), Control VNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
4.Secondary Outcome
Title Wolf Motor Function Test (WMFT) Average Change
Hide Description The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT 90-day - is a measure of the functional assessment change from baseline to 90 days after 6-weeks of therapy.
Time Frame V7, 90 days after 6-weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description:

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.46  (0.40) 0.16  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS + Rehabilitation (1), Control VNS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VNS + Rehabilitation (1) Control VNS
Hide Arm/Group Description

Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.

Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Rehabilitation: Rehabilitation movements to improve upper limb function after stroke

All-Cause Mortality
VNS + Rehabilitation (1) Control VNS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)      0/55 (0.00%)    
Hide Serious Adverse Events
VNS + Rehabilitation (1) Control VNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/53 (9.43%)      3/55 (5.45%)    
Gastrointestinal disorders     
Colinic Diverticular Abscess * 1 [1]  1/53 (1.89%)  1 0/55 (0.00%)  0
Injury, poisoning and procedural complications     
Dysphonia * 1 [2]  0/53 (0.00%)  0 1/55 (1.82%)  1
Fall * 1 [3]  2/53 (3.77%)  2 1/55 (1.82%)  1
Nervous system disorders     
Seizure * 1 [4]  1/53 (1.89%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Acute Kidney Injury (AKI)/ chronic kidney disease (CKD) * 1 [5]  0/53 (0.00%)  0 1/55 (1.82%)  1
Urinary Tract Infection (UTI) * 1 [6]  1/53 (1.89%)  1 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
[1]
Subject reported pain and achiness at home. ER assessment indicated CDA. CDA drained and antibiotics started; subject returned home and recovered. No relationship to device implant or stimulation.
[2]
Subject experienced vocal cord paresis and dysphonia after surgery. Recovered over 5 weeks; laryngoscope confirmed complete recovery. Related to the implant procedure but not stimulation. Subject recovered and continued in the study.
[3]
1 Subject fell at home walking down steps; fractured two vertebrae. 1 Subject fell at hospital during testing. 1 subject fell at home and broke her humerus. Subjects missed visits but continued in the study. No relationship to surgery or therapy.
[4]
Patient with history of seizures had one during the 5th week of study treatment. Admitted to the ICU, recovered, was discharged, and continued in the study. The device implant and device stimulation are not related to this event (patient history).
[5]
The patient was hospitalized after 7-8 months of worsening swelling and dyspnea on exertion (pre study). Found to have acute onset kidney injury (AKI on Chronic Kidney Disease [CKD]). Patient recovered and continued. Not related to implant or stim.
[6]
Subject hospitalized with urinary tract infection. Subject recovered and continued in the study. No relationship to implant surgery or stimulation.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VNS + Rehabilitation (1) Control VNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/53 (81.13%)      42/55 (76.36%)    
Gastrointestinal disorders     
Vomiting * 1  2/53 (3.77%)  2 7/55 (12.73%)  7
General disorders     
Pain * 1  5/53 (9.43%)  5 7/55 (12.73%)  7
Fatigue * 1  3/53 (5.66%)  3 2/55 (3.64%)  2
Injury, poisoning and procedural complications     
Coughing/Hoarseness * 1  8/53 (15.09%)  8 10/55 (18.18%)  10
Bruise * 1  8/53 (15.09%)  8 4/55 (7.27%)  4
Local Throat Irritation * 1  3/53 (5.66%)  3 3/55 (5.45%)  3
Nervous system disorders     
Dizziness * 1  3/53 (5.66%)  3 3/55 (5.45%)  3
Psychiatric disorders     
Low Mood * 1  5/53 (9.43%)  5 4/55 (7.27%)  4
Skin and subcutaneous tissue disorders     
Rash * 1  3/53 (5.66%)  3 0/55 (0.00%)  0
Vascular disorders     
Headache * 1  3/53 (5.66%)  3 2/55 (3.64%)  2
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: MicroTransponder Inc.
Phone: 8556289375
EMail: studies@microtransponder.com
Layout table for additonal information
Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT03131960    
Other Study ID Numbers: MT-St-03
First Submitted: April 24, 2017
First Posted: April 27, 2017
Results First Submitted: April 27, 2021
Results First Posted: June 14, 2021
Last Update Posted: March 31, 2022