Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

Official title

Pre-Frontal tDCS as a Novel Intervention to Reduce Effects of Post-Stroke Fatigue While Improving Language and Attention in Aphasia

Overview

The goal of this clinical trial is to determine if electrical brain stimulation applied to the front parts of the brain can help people who have had a stroke improve their fatigue, language, and attention. The main question it aims to answer is: * Does transcranial direct current stimulation (tDCS) administered to the pre-frontal areas of the brain improve post-stroke fatigue and aphasia? * What kinds of participant characteristics are associated with better improvement of post-stroke fatigue and aphasia? Researchers will compare active electrical stimulation to sham stimulation to see if the active stimulation does a better job at reducing fatigue and language deficits after stroke. Participants will be asked to complete fatigue, language, and cognitive testing before and after receiving 10 sessions of tDCS plus speech and language therapy.

Interventions

• Device tDCS (active)
  The investigators will administer active tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For active tDCS, the current will slowly be increased to 2mA and applied for 20 minutes.
• Behavioral Attention-focused sentence comprehension treatment
  This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. Participants will receive 10 sessions of this treatment.
• Behavioral Sentence comprehension treatment
  This is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment.
• Device tDCS (sham)
  The investigators will administer sham tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For sham tDCS, the current will slowly be increased to 2mA over the course of 30 seconds and then immediately ramped back down to zero.

Primary outcome measures

• Fatigue Interference and Severity Scale for Aphasia (FISS-A) [Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up]

Secondary outcome measures (3)

• Continuous Performance Test (CPT) [Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up]
• Attention Network Test (ANT) [Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up]
• Sentence comprehension task [Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up]

Eligibility criteria

Inclusion criteria

• 18 years or older.
• No diagnosis of neurological disorder (other than stroke).
• No diagnosis of psychiatric disorder, with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
• No seizure within the past 6 months.
• Not pregnant.
• Does not currently have cardiac pacemaker
• In chronic phase of recovery, defined as at least 6 months post-stroke.
• Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
• No metal implants in the scalp or bone in the pre-frontal area of the head.
• No unhealed skull fractures.
• Onset of aphasia related to single, left hemisphere, ischemic stroke.
• Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
• Mild to moderate aphasia (as measured by WAB-R \*\*or QAB).
• Self-report of post-stroke fatigue (as measured on SF-CAT)
• No significant challenges with vision or hearing (with use of corrective aids if needed; eyeglasses, hearing aids).
• Willing to allow audio-recording of study sessions.

Exclusion criteria

• Younger than 18 years old.
• Diagnosis or history of neurological disorder other than stroke.
• Diagnosis or history of psychiatric disorder with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
• History of seizures within the past 6 months.
• Pregnant.
• Currently has cardiac pacemaker
• <6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
• Currently undergoing speech and language therapy targeting auditory comprehension or attention.
• Metal implants in the scalp or bone in the pre-frontal area of the head.
• Currently has an unhealed skull fracture.
• Onset of aphasia related to etiology other than ischemic left hemisphere stroke.
• Damaged brain tissue significantly overlaps with left hemisphere dorsolateral prefrontal cortex.
• No aphasia or severe aphasia (as measured by WAB-R \*\*or QAB).
• Does not report experience of post-stroke fatigue (as measured on SF-CAT)
• Significant challenges with vision and/or hearing (even with use of corrective aids).
• Unwilling to allow audio-recording of study sessions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• University of Michigan — Ann Arbor
• Syracuse University — Syracuse

Identifiers

NCT: NCT07151677 · 1R01DC021677-01A1 · 1R01DC021677-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗