Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

NCT02270866 | Completed

• 1 other identifier: SNS-APH-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (CVS) in patients with post-stroke aphasia. CVS is delivered via a portable, non-invasive device. Both language and movement assessments are made.

Conditions

Post-stroke Aphasia

Keywords

aphasia; stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Mood & QoL

  after completing 84 days of device use

• Gait and posture

  after completing 84 days of device use

• Heart rate variability (HRV)

  after completing 84 days of device use

• Durability of gains

  3 months after the completion of therapy

Study Arms (1)

Caloric Vestibular Stimulation (CVS)

EXPERIMENTAL

Device: TNM Device

Interventions

TNM Device DEVICE

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.

Caloric Vestibular Stimulation (CVS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (1)