Clinical trial NCT05093673: Cerebellar Stimulation for Aphasia Rehabilitation
Official title: Cerebellar Stimulation for Aphasia Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The optimal site of neuromodulation for post-stroke aphasia has yet to be established. This study will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia as well as predict who is likely to respond to cerebellar tDCS.

Detailed description: Aphasia is a devastating complication of stroke. Speech and language treatment (SLT) can be helpful in restoring language function, but not all individuals show improvement. Recent studies indicate that Transcranial Direct Current Stimulation (tDCS) is a promising adjuvant approach to enhance the effectiveness of SLT. tDCS is a noninvasive, non-painful, electrical stimulation of the brain. It is believed that tDCS boosts neural plasticity that underlies recovery with SLT. A majority of the tDCS studies of aphasia have stimulated the left hemisphere regions. However, left hemisphere lesions common in post-stroke aphasia affect the electrical field in unpredictable ways, potentially preventing stimulation from reaching perilesional tissue associated with optimal recovery. The investigators' prior work addressed this problem by stimulating a novel region, the right cerebellum. The right cerebellum is connected to the left hemisphere and involved in a variety of cognitive and language functions, including naming, which is often impaired in people with aphasia. The investigators' work has shown that cerebellar tDCS is safe, easily tolerated, and improved language skills in a number of stroke participants with aphasia. The proposed project will build on these findings by conducting a randomized, double-blind, sham-controlled, trial to determine the effectiveness of cathodal tDCS to the right cerebellum for the treatment of post-stroke aphasia. The investigators will test the hypothesis that 15 sessions of cerebellar tDCS combined with an evidenced-based anomia treatment (semantic feature analysis, SFA) is associated with greater gains in accuracy in naming pictures, compared to 15 sessions of sham combined with semantic feature analysis

Eligibility criteria: Inclusion Criteria:

* Chronic ischemic or hemorrhagic left hemisphere stroke
* Fluent speaker of English by self-report
* Age 18 or older
* 6 months post onset of stroke
* Diagnosis of aphasia and naming impairment using the Western Aphasia Battery-Revised

Exclusion Criteria:

* Lesion in the right cerebellum
* Previous neurological disorder (other than stroke) affecting the brain, or any other neurodegenerative disorder or psychiatric disorder
* Seizures during the previous 6 months
* Uncorrected visual loss or hearing loss by self-report
* Use of medications that lower the seizure threshold (e.g., methylphenidate)
* Use of N-methyl-D-aspartate (NMDA) antagonists (e.g., memantine)
* \>80% correct response on the Philadelphia Naming Testing at baseline
* History of brain surgery or any metal in the head
* Severely impaired auditory comprehension (lower than 2 on the Comprehension subscore on the Western Aphasia Battery-Revised)
* Severely limited verbal output (lower than 2 on the Spontaneous Speech rating scale on the Western Aphasia Battery-Revised)
* Individuals with severe claustrophobia, cardiac pacemakers or ferromagnetic implants, and pregnant women will be excluded from the MRI portion of the study.

Primary outcomes:
measure: Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
timeFrame: Pre-treatment to one week after the end of SFA treatment
Secondary outcomes:
measure: Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
timeFrame: Pre-treatment and at 1, 3 and 6 months post treatment
measure: Change in accuracy of naming trained pictures
timeFrame: Pre-treatment to one week after the end of SFA treatment
measure: Change in accuracy of naming trained pictures
timeFrame: Pre-treatment and at 1, 3 and 6 months post treatment
measure: Change in the total content units produced during picture description.
timeFrame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
measure: Change in the syllable per content units produced during picture description.
timeFrame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
measure: Change in functional communication skills
timeFrame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
measure: Change in Stroke and Aphasia Quality of Life (SAQOL) scale
timeFrame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
measure: Change in General Health Questionnaire-12 item (GHQ-12)
timeFrame: Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rajani Sebastian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sebastian R, Saxena S, Tsapkini K, Faria AV, Long C, Wright A, Davis C, Tippett DC, Mourdoukoutas AP, Bikson M, Celnik P, Hillis AE. Cerebellar tDCS: A Novel Approach to Augment Language Treatment Post-stroke. Front Hum Neurosci. 2017 Jan 12;10:695. doi: 10.3389/fnhum.2016.00695. eCollection 2016.
citation: Sebastian R, Kim JH, Brenowitz R, Tippett DC, Desmond JE, Celnik PA, Hillis AE. Cerebellar neuromodulation improves naming in post-stroke aphasia. Brain Commun. 2020 Nov 9;2(2):fcaa179. doi: 10.1093/braincomms/fcaa179. eCollection 2020.