Post-stroke AphasiaNCT02270866
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
A study testing TNM Device in people with Post-stroke Aphasia, run by Scion NeuroStim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-stroke Aphasia
- What is being tested?
- TNM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >6 months post-stroke (ischemic or hemorrhagic)
- receptive or expressive aphasia
- little or no improvement in language ability in the preceding 3 months
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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
- Being tested
- TNM Device
- Keywords
- aphasia, stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Not described Receives: Device: TNM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after completing 84 days of device use
Secondary outcomes (4)
Mood & QoL
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, and for QoL: Stroke impact scale (short form), Everyday Cognition.
Measured: 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.
Measured: after completing 84 days of device use
Heart rate variability (HRV)
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.
Measured: after completing 84 days of device use
Durability of 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.
Measured: 3 months after the completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270866
- Sponsor's protocol ID
- SNS-APH-01
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2014
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT02270866
- Acronym / sponsor ID
- SNS-APH-01
- Conditions
- Post-stroke Aphasia
- Keywords
- aphasia, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental | Device: TNM Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >6 months post-stroke (ischemic or hemorrhagic)
- receptive or expressive aphasia
- little or no improvement in language ability in the preceding 3 months
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNM DeviceThe 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. | Device | Caloric Vestibular Stimulation (CVS) |
Primary outcome
Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
Time frame: after completing 84 days of device use
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.
4 secondary outcomes
Mood & QoL
Time frame: after completing 84 days of device use
Gait and posture
Time frame: after completing 84 days of device use
Heart rate variability (HRV)
Time frame: after completing 84 days of device use
Durability of gains
Time frame: 3 months after the completion of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Related trials for Post-stroke Aphasia
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNM Device in people with Post-stroke Aphasia, run by Scion NeuroStim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period (time frame: after completing 84 days of device use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.