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Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Primary Purpose

Post-stroke Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TNM(trademark) - thermoneuromodulation
Sponsored by
Scion NeuroStim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Aphasia focused on measuring aphasia, stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >6 months post-stroke (ischemic or hemorrhagic)
  • receptive or expressive aphasia
  • little or no improvement in language ability in the preceding 3 months

Exclusion Criteria:

  • persons under the age of 18 or over the age of 75
  • patients with pure receptive aphasia
  • co-morbid CNS disease
  • primary motor/oral apraxia
  • pregnant or nursing women
  • have a history of unstable mood disorder or unstable anxiety disorder or psychosis
  • use of a hearing aid
  • have a cochlear implant
  • have a diagnosed vestibular dysfunction
  • abuse alcohol or other drugs
  • have had eye surgery within the previous three months or ear surgery within the previous six months
  • have active ear infections or a perforated tympanic membrane
  • have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
  • Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TNM(trademark) - thermoneuromodulation

Arm Description

TNM (thermoneuromodulation device). A standardized active thermal neuromodulation waveform will be used for all patients. The device is noninvasive and does not use electrical stimulation.

Outcomes

Primary Outcome Measures

Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
At the end of the 84 day period of device use, the patient's verbal fluency will be compared with the baseline level to assess any improvement. Boston Diagnostic Aphasia exam, Hopkins verbal learning test, oral symbol digit modality test, oral trail marking test.

Secondary Outcome Measures

Mood
At the end of the 84 day period of device use, the patient's mood will be compared with the baseline scores to assess any improvement. Patient Health Questionnaire-9, Beck Depression Inventory
gait and posture
At the end of the 84 day period of device use, the patient's gait and posture will be compared with the baseline levels to assess any improvement. This is a blended measure employing Timed Up & Go and a 10-meter walk.
heart rate variability
At the end of the 84 day period of device use, the patient's HRV values will be compared with those from the baseline period to assess any improvement.
durability of any gains
Three months after the completion of the therapy period, measurements of verbal fluency, mood & QOL, gait & posture and HRV will be completed and compared with the values from the end of the treatment period to assess durability of any gains.
Quality of Life
At the end of the 84 day period of device use, the patient's QOL will be compared with the baseline scores to assess any improvement. Stroke impact scale (short form), Everyday Cognition.

Full Information

First Posted
October 14, 2014
Last Updated
October 15, 2016
Sponsor
Scion NeuroStim
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02270866
Brief Title
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Official Title
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim
Collaborators
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study with a single active treatment arm. The study is designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of post-stroke aphasia. Both language and movement assessments will be made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Aphasia
Keywords
aphasia, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNM(trademark) - thermoneuromodulation
Arm Type
Experimental
Arm Description
TNM (thermoneuromodulation device). A standardized active thermal neuromodulation waveform will be used for all patients. The device is noninvasive and does not use electrical stimulation.
Intervention Type
Device
Intervention Name(s)
TNM(trademark) - thermoneuromodulation
Intervention Description
The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Primary Outcome Measure Information:
Title
Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
Description
At the end of the 84 day period of device use, the patient's verbal fluency will be compared with the baseline level to assess any improvement. Boston Diagnostic Aphasia exam, Hopkins verbal learning test, oral symbol digit modality test, oral trail marking test.
Time Frame
after completing 84 days of device use
Secondary Outcome Measure Information:
Title
Mood
Description
At the end of the 84 day period of device use, the patient's mood will be compared with the baseline scores to assess any improvement. Patient Health Questionnaire-9, Beck Depression Inventory
Time Frame
after completing 84 days of device use
Title
gait and posture
Description
At the end of the 84 day period of device use, the patient's gait and posture will be compared with the baseline levels to assess any improvement. This is a blended measure employing Timed Up & Go and a 10-meter walk.
Time Frame
after completing 84 days of device use
Title
heart rate variability
Description
At the end of the 84 day period of device use, the patient's HRV values will be compared with those from the baseline period to assess any improvement.
Time Frame
after completing 84 days of device use
Title
durability of any gains
Description
Three months after the completion of the therapy period, measurements of verbal fluency, mood & QOL, gait & posture and HRV will be completed and compared with the values from the end of the treatment period to assess durability of any gains.
Time Frame
3 months after the completion of therapy
Title
Quality of Life
Description
At the end of the 84 day period of device use, the patient's QOL will be compared with the baseline scores to assess any improvement. Stroke impact scale (short form), Everyday Cognition.
Time Frame
after completing 84 days of device use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >6 months post-stroke (ischemic or hemorrhagic) receptive or expressive aphasia little or no improvement in language ability in the preceding 3 months Exclusion Criteria: persons under the age of 18 or over the age of 75 patients with pure receptive aphasia co-morbid CNS disease primary motor/oral apraxia pregnant or nursing women have a history of unstable mood disorder or unstable anxiety disorder or psychosis use of a hearing aid have a cochlear implant have a diagnosed vestibular dysfunction abuse alcohol or other drugs have had eye surgery within the previous three months or ear surgery within the previous six months have active ear infections or a perforated tympanic membrane have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

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