Cerebellar Stimulation for Aphasia Rehabilitation
CeSAR
3 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2021
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 20, 2026
March 1, 2026
5.9 years
October 13, 2021
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
Behavioral measure of change in untrained naming. Scores ranges from 0 to 175 with higher scores meaning better naming ability.
Pre-treatment to one week after the end of SFA treatment
Secondary Outcomes (8)
Change in accuracy of naming untrained pictures (Philadelphia Naming Test)
Pre-treatment and at 1, 3 and 6 months post treatment
Change in accuracy of naming trained pictures
Pre-treatment to one week after the end of SFA treatment
Change in accuracy of naming trained pictures
Pre-treatment and at 1, 3 and 6 months post treatment
Change in the total content units produced during picture description.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
Change in the syllable per content units produced during picture description.
Pre-treatment, 1 week, 1, 3, and 6 months post treatment
- +3 more secondary outcomes
Study Arms (2)
Cathodal Cerebellar tDCS and SFA
ACTIVE COMPARATORCathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming
Sham Cerebellar tDCS and SFA
SHAM COMPARATORSham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.
Interventions
Semantic Feature Analysis (SFA) is a treatment technique designed to improve lexical retrieval by increasing the level of activation within a semantic network. The treatment will proceed according to a series of steps including naming aloud the target picture, generating semantic features, naming aloud the target picture again, and generating a sentence using the target word.
2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
2 mA of cathodal tDCS is induced between two 5cm X 5cm saline soaked sponges where the cathode sponge is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes.
Eligibility Criteria
You may qualify if:
- Chronic ischemic or hemorrhagic left hemisphere stroke
- Fluent speaker of English by self-report
- Age 18 or older
- months post onset of stroke
- Diagnosis of aphasia and naming impairment using the Western Aphasia Battery-Revised
You may not qualify if:
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (4)
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.
PMID: 28127284BACKGROUNDSebastian 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.
PMID: 33241212BACKGROUNDLammers B, Sydnor MJ, Cust S, Kim JH, Yenokyan G, Hillis AE, Sebastian R. Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial. PLoS One. 2024 Aug 26;19(8):e0298991. doi: 10.1371/journal.pone.0298991. eCollection 2024.
PMID: 39186573DERIVEDLammers B, Sydnor MJ, Cust S, Kim JH, Yenokyan G, Hillis AE, Sebastian R. Protocol for Cerebellar Stimulation for Aphasia Rehabilitation (CeSAR): A randomized, double-blind, sham-controlled trial. medRxiv [Preprint]. 2024 Feb 6:2024.02.05.24302365. doi: 10.1101/2024.02.05.24302365.
PMID: 38370630DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajani Sebastian, PhD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 26, 2021
Study Start
October 25, 2021
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).