Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Aphasia
• Intervention / Treatment: Device: TNM(trademark) - thermoneuromodulation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNM(trademark) - thermoneuromodulation; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Scion NeuroStim
• Collaborators: Duke University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 15, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: stroke; aphasia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: SNS-APH-01