Stuttering, DevelopmentalNCT03437512

Non-invasive Brain Stimulation in Adults Who Stutter

A study testing Anodal tDCS and Fluency training in people with Stuttering, Developmental, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Stuttering, Developmental
What is being tested?: Anodal tDCS and Fluency training
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 25 Jun 2018to 1 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

history of persistent developmental stuttering
stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
scores within 1 standard deviation of the norm on the standardized tests for the study

Who cannot join

received any treatment for stuttering within the past year
other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
taking any medications/drugs that affect brain function
history of past or current mental illness for example, schizophrenia that may affect brain development and function
history of serious medical or neurological illness such as epilepsy and Parkinson's disease
history of closed head injury (e.g., concussion)

Show all 10Show fewer

history of reading disorders
hearing loss
taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study
metal or electronic implants such as cochlear implants, and pacemakers

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48105

Other trials in United States

About this study

Conditions: Stuttering, Developmental
Being tested: Anodal tDCS, Fluency training, Sham tDCS
Keywords: transcranial direct current stimulation, MRI, Speech, fluency, tDCS
Medical subject headings: Stuttering, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anodal tDCSDevice
20 minutes of 2mA anodal stimulation.
Fluency trainingBehavioural
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes
Sham tDCSDevice
For sham stimulation, current is ramped up and back down over 30 seconds.

Study groups in NCT03437512
Study group	Role	What they receive
Active tDCS and fluency training	Experimental	Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Receives: Device: Anodal tDCS; Behavioral: Fluency training
Sham tDCS and fluency training	Sham comparator	Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Receives: Behavioral: Fluency training; Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Brain Activation as Assessed by fMRI Images
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for [post-pre] and [follow up-pre] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.
Measured: Baseline, 1 week (post), 4 weeks (follow up)
Change in Percentage of Stuttered Syllables Produced During Speech Sample
Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).
Measured: Baseline, 1 week (post), 4 weeks (follow up)

Secondary outcomes (1)

Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)
The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 most negative impact). These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. The change on the total impact score will be used. Changes are shown in the table below by comparison between the measurements at the three points in time.
Measured: Baseline, 1 week (post), 4 weeks (follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 20181 Apr 2020

First posted19 Feb 2018
Study start25 Jun 2018
Primary completion1 Apr 2020
Study completion1 Apr 2020

Why it stopped: Covid-19 paused human subjects research at study site, funding expired.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stuttering, DevelopmentalStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03437512
Sponsor's protocol ID: HUM00134495
Status last verified: Apr 2021
First submitted: 12 Feb 2018
Last updated: 29 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Noninvasive Thalamocortical Neuromodulation With Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering
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All Stuttering, Developmental trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Brain Stimulation in Adults Who Stutter
ClinicalTrials.gov ID: NCT03437512
Acronym / sponsor ID: HUM00134495
Conditions: Stuttering, Developmental
Keywords: transcranial direct current stimulation, MRI, Speech, fluency, tDCS
Study type: Interventional
Recruitment status: TerminatedReason stopped: Covid-19 paused human subjects research at study site, funding expired.
Enrolment: 29 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 25 Jun 2018 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 29 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tDCS and fluency training	Experimental	Device: Anodal tDCS, Behavioral: Fluency trainingParticipants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).
Sham tDCS and fluency training	Sham comparator	Behavioral: Fluency training, Device: Sham tDCSParticipants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

history of persistent developmental stuttering
stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
scores within 1 standard deviation of the norm on the standardized tests for the study

Key exclusion criteria (10 listed)

received any treatment for stuttering within the past year
other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
taking any medications/drugs that affect brain function
history of past or current mental illness for example, schizophrenia that may affect brain development and function
history of serious medical or neurological illness such as epilepsy and Parkinson's disease

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
Anodal tDCS20 minutes of 2mA anodal stimulation.	Device	Active tDCS and fluency training
Fluency trainingSpeaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes	Behavioural	Active tDCS and fluency training, Sham tDCS and fluency training
Sham tDCSFor sham stimulation, current is ramped up and back down over 30 seconds.	Device	Sham tDCS and fluency training

Primary outcome

Changes in Brain Activation as Assessed by fMRI Images
Time frame: Baseline, 1 week (post), 4 weeks (follow up)
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for [post-pre] and [follow up-pre] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.
Change in Percentage of Stuttered Syllables Produced During Speech Sample
Time frame: Baseline, 1 week (post), 4 weeks (follow up)
Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).

1 secondary outcome

Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)
Time frame: Baseline, 1 week (post), 4 weeks (follow up)

Results and safety

Results posted to the registry on 29 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS and Fluency Training	12	12
Sham tDCS and Fluency Training	13	11

Primary outcome: Changes in Brain Activation as Assessed by fMRI Images

Time frame: Baseline, 1 week (post), 4 weeks (follow up). Mean (Standard Deviation). Unit: Percent signal change

Measure	Active tDCS and Fluency Training n = 11	Sham tDCS and Fluency Training n = 10
left supplementary motor area (SMA) (post-pre)	1.39 (0.45)	0.81 (0.47)
left SMA (fol-pre)	1.03 (0.49)	0.9 (0.54)
right SMA (post-pre)	-0.45 (0.48)	0.49 (0.52)
right SMA (fol-pre)	0.86 (0.54)	0.09 (0.35)
left superior temporal gyrus (STG) (post-pre)	1.43 (0.74)	0.79 (0.75)
left STG (fol-pre)	0.09 (0.53)	0.57 (0.85)
right STG (post-pre)	-0.63 (0.97)	1.56 (1.39)
right STG (fol-pre)	0.3 (1.07)	0.83 (1.17)

Active tDCS and Fluency Training vs Sham tDCS and Fluency Training: p <.001, t-test, 2 sided

Population analysed: One subject assigned to the sham condition did not want to participate in the MRI but participated in every other aspect of the study. Additionally, 2 subjects assigned to active and 1 assigned to sham did not complete follow up MRI due to pandemic research pause. The MRI data from one subject in the active arm was corrupted and therefore not analyzable and was excluded from MRI results. Therefore \[post-pre\] includes 11 active and 10 sham, whereas \[follow up-pre\] includes 9 active and 9 sham.

Primary outcome: Change in Percentage of Stuttered Syllables Produced During Speech Sample

Time frame: Baseline, 1 week (post), 4 weeks (follow up). Mean (Standard Deviation). Unit: percent change in stuttered syllables

Measure	Active tDCS and Fluency Training n = 12	Sham tDCS and Fluency Training n = 11
% Change post	-1.82 (2.22)	1.06 (2.02)
% Change follow up	-1.03 (4.17)	3.46 (5.47)

Active tDCS and Fluency Training vs Sham tDCS and Fluency Training: p = .936, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS and Fluency Training	0 of 12 (0%)	12 of 12 (100%)	0 of 12
Sham tDCS and Fluency Training	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11

Limitations and caveats (from the sponsor): Study was terminated early due to pandemic research pause, which resulted in fewer enrolled subjects than anticipated, which affected the number of subjects that could be analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stuttering, Developmental

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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.

Emily O Garnett, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anodal tDCS and Fluency training in people with Stuttering, Developmental, run by University of Michigan 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 10 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: stopped early, as of the sponsor's last update on 29 Apr 2021. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Brain Activation as Assessed by fMRI Images (time frame: Baseline, 1 week (post), 4 weeks (follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437512.

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 29 Apr 2021.