Paired vagus nerve stimulation for improved upper limb function after stroke

Not Applicable

Completed

• Conditions: Subjects 9 months to 10 years post ischemic stroke who have upper limb deficits; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN14280559
• Lead Sponsor: MicroTransponder Inc.

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31903435/ (added 02/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33894832/ (added 02/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Study Completion: 2020-02-28
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. History of unilateral supratentorial ischemic stroke that occurred at least 9 months but not more than ten 10 years prior to enrollment
2. Age >22 years and <80 years
3. FMA-UE score of 20 to 50 (inclusive of 20 and 50)
4. Ability to communicate, understand, and give appropriate consent. Subjects should be able to follow two-step commands
5. Right- or left-sided weakness of upper extremity
6. Active wrist flexion/extension; active abduction/extension of thumb and at least two additional digits

Exclusion Criteria

1. History of hemorrhagic stroke
2. Presence of ongoing dysphagia or aspiration difficulties
3. Subject receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry. A list of excluded medications will be provided to Investigators
4. Prior injury to vagus nerve, either bilateral or unilateral (e.g., injury during carotid endarterectomy).
5. Severe or worse depression (Beck Depression Scale > 29) (Beck et al., 1961)
6. Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon’s opinion, etc)
7. Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug
8. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline
9. Pregnancy or plans to become pregnant or to breastfeed during the study period
10. Current requirement, or likely future requirement, of diathermy during the study duration
11. Active rehabilitation within 4 weeks prior to consent
12. Botox injections or any other non-study active rehabilitation of the upper extremity within 4 weeks prior to therapy through the post-30 day visit (Visit 6)
13. Severe spasticity of the upper limb (Modified Ashworth =3) (Bohannon and Smith, 1987)
14. Significant sensory loss. Sensory loss will be measured using the Upper Extremity sensory section of the Fugl Meyer Assessment of Physical Performance. The assessment addresses light touch (2 items) and proprioception (4 items).The highest points attained is 12; subjects with scores less than 6 will be excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impairment, measured using the Fugl-Meyer Assessment, Upper Extremity portion (FMA-UE) at Stage I: Visits 1, 2, 4, 5, 6 and 7; Stage II (VNS Treatment Arm): 6, 9 and 12 months; Stage IIb: 1 day and 30 days; Stage II (Control Arm): 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Upper extremity function, measured using the Wolf Motor Function Test (WMFT) at Stage I: Visits 2, 4, 5, 6, 7; Stage II (VNS Treatment Arm) 6, 9 and 12 months; Stage IIb: 1 day and 30 days; Stage II (Control Arm): 3, 6, 9 and 12 months<br> 2. Health-related quality of life, measured using the Stroke Impact Scale (SIS) at Stage 1: Visit 4, 5, 7; Stage II (VNS Treatment Arm): 6 and 12 months; Stage IIb: 1 day; Stage II (Control Arm): 3 and 12 months<br> 3. Stroke-specific quality of life, measured using Stroke Specific Quality of LIfe (SS-QOL) at Stage 1: Visit 4, 5, 7; Stage II (VNS Treatment Arm): 6 and 12 months; Stage IIb: 1 day; Stage II (Control Arm): 3 and 12 months<br> 4. Activities of daily living, assessed using Motor Activity Log (MAL) at Stage 1: Visit 4, 5, 7; Stage II (VNS Treatment Arm): 6 and 12 months<br>