Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Post-stroke Aphasia Clinical Trial

Official title:

Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270866
• Other study ID #: SNS-APH-01
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: October 15, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Scion NeuroStim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Post-stroke Aphasia
• Stroke

Intervention

Device:
• TNM(trademark) - thermoneuromodulation
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Scion NeuroStim	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after completing 84 days of device use	No
Secondary	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	after completing 84 days of device use	No
Secondary	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.	after completing 84 days of device use	No
Secondary	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.	after completing 84 days of device use	No
Secondary	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.	3 months after the completion of therapy	No
Secondary	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.	after completing 84 days of device use	No