NCT05093673

Cerebellar Stimulation for Aphasia Rehabilitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Cathodal Cerebellar tDCS	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.
BEHAVIORAL	Semantic Feature Analysis (SFA)	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.
DEVICE	Sham	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.

Timeline

• Start date: 2021-10-25
• Primary completion: 2027-09-01
• Completion: 2028-04-01
• First posted: 2021-10-26
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States