Clinical trial NCT05194566: Neurostimulation for the Treatment of Post-Stroke Aphasia
Official title: Neurostimulation for the Treatment of Post-Stroke Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Aphasia
Keywords: speech therapy
brain stimulation
communication
language
Lead sponsor: Neuro Device S.A
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2022-01-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will employ a between-subject randomized sham-controlled design.
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.

Detailed description: There are about 15 million strokes worldwide each year. Of this group, about 30% suffer from aphasia. Aphasia is a speech-language disorder associated with exceptional difficulty performing daily communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years.

Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding.

In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia.

To boost the effects of aphasia rehabilitation, effective brain stimulation protocol still needs to be developed.

Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity.

Stimulation within high gamma oscillations (60-500Hz) might allow for better speech-language processing, as this band is considered to be the cognitive index of linguistic processes. Moreover, a short period of 75Hz tACS over the motor cortex suggested the positive impact of high-gamma tACS on brain plasticity.

The aim of this RCT is to determine whether 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia, measured as an ability to name trained items at 12 weeks follow-up.

Eligibility criteria: Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements.

Inclusion Criteria:

* diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
* presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
* chronic stage of the disease - time since the stroke occurred over 6 months.
* ability to achieve an accuracy in the Naming Task of 10-60%.
* 18-80 years
* right-handedness before the stroke.
* ability to give informed written consent.
* fluency in English.

Exclusion Criteria:

* severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
* presence of metal implants in the skull.
* presence of major untreated or unstable psychiatric disease.
* history of epilepsy or seizures.
* ongoing medication that increases the risk of epileptic seizures.
* presence in the body of cardiac stimulators or pacemaker.
* history of speech, language, hearing, or intellectual disability during childhood.
* pregnancy (based on declarations)

Exclusion criteria during the trial:

* high intolerance to stimulation.
* occurrence of an epileptic seizure.
* other previously absent neurological or mental symptoms

Withdrawal criteria:

* high intolerance to stimulation (participants experience severe discomfort during stimulation);
* occurrence of an epileptic seizure;
* other previously absent neurological, physical or mental symptoms.

Primary outcomes:
measure: Percentage score in the Naming Task (trained words)
timeFrame: at 12 weeks
Secondary outcomes:
measure: Naming Task (untrained words)
timeFrame: at 12 weeks
measure: Naming reaction time (within baseline naming task)
timeFrame: at Baseline
measure: Naming reaction time (within baseline naming task)
timeFrame: at 12-week follow-up
measure: Number of correct answers without supporting cues
timeFrame: 2 weeks
measure: Accuracy of naming during the therapy session
timeFrame: 2 weeks
measure: Percentage Score in Naming Task (untrained words)
timeFrame: at Baseline
measure: Percentage Score in Naming Task (untrained words)
timeFrame: at the end of the last therapy session at the end of week 4
measure: Percentage Score in Naming Task (untrained words)
timeFrame: at 6-week follow-up
measure: Percentage Score in Naming Task (untrained words)
timeFrame: at 12-week follow-up
measure: Communication Effectiveness Index (CETI)
timeFrame: at Baseline
measure: Communication Effectiveness Index (CETI)
timeFrame: at the end of the last therapy session at the end of week 4
measure: Communication Effectiveness Index (CETI)
timeFrame: at 6-week follow-up
measure: Communication Effectiveness Index (CETI)
timeFrame: at 12-week follow-up
measure: Boston Diagnostic Aphasia Examination (BDAE)
timeFrame: at Baseline
measure: Boston Diagnostic Aphasia Examination (BDAE)
timeFrame: at 12-week follow-up
measure: Accuracy of masking measurement: Patient and Researcher
timeFrame: end of treatment (at 12 weeks)
measure: Visual Analog Scale (VAS)
timeFrame: 2 weeks
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
timeFrame: at Baseline
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
timeFrame: at the end of the last therapy session at the end of week 4
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
timeFrame: at 6-week follow-up
measure: Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
timeFrame: at 12-week follow-up
measure: General Health Questionnaire (GHQ-12)
timeFrame: at Baseline
measure: General Health Questionnaire (GHQ-12)
timeFrame: at the end of the last therapy session at the end of week 4
measure: General Health Questionnaire (GHQ-12)
timeFrame: at 6-week follow-up
measure: General Health Questionnaire (GHQ-12)
timeFrame: at 12-week follow-up
measure: Brief Resilience Scale (BRS)
timeFrame: at Baseline
measure: Brief Resilience Scale (BRS)
timeFrame: at the end of the last therapy session at the end of week 4
measure: Brief Resilience Scale (BRS)
timeFrame: at 6-week follow-up
measure: Brief Resilience Scale (BRS)
timeFrame: at 12-week follow-up
measure: BDNF genotype
timeFrame: at Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Miguel Escalon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.