Recruiting

Brain Stimulation

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05660304

Conditions

Stroke

Aphasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cortico-cortical paired associative stimulation

Sham cortico-cortical paired associative stimulation

Study Details

Brief summary:

The overall goal of this study is to evaluate whether stimulation of two brain areas alongside behavioral speech-language therapy increases connectivity to improve language functions in stroke-aphasia patients.

Conditions

Stroke

Aphasia

Study ID

NCT05660304

Start date

Jan 9, 2023

Status verified date

Dec, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Aug 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of non-fluent aphasia due to a single, left-hemisphere stroke
2. ≧ six months post-stroke onset
3. WAB-R Fluency, Grammatical Competence, and Paraphasias Score between 2-6
4. 18+ years of age
5. Premorbidly right-handed
6. English-speaking
7. Ability to participate in fMRI / TMS protocol

Exclusion Criteria:

1. Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
2. Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
3. Surgical clips in the head or previous neurosurgery
4. Any magnetic particles in the body
5. Cochlear implants
6. Prosthetic heart valves
7. Epilepsy or any other type of seizure history
8. History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
9. Significant other disease (heart disease, malignant tumors, mental disorders)
10. Significant claustrophobia
11. Ménière's disease
12. Medications that increase risk of seizures, for instance antipsychotic and antidepressant medications acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
13. Non-prescribed drug use, for instance recreational marijuana
14. Unable to refrain from using any alcohol and nicotine products for at least 24 hours before the study Visits.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ccPAS group

Patients under this group will receive ccPAS followed by speech-language therapy.

sham comparator: Sham ccPAS group

Patients under this group will receive sham ccPAS followed by speech-language therapy.

Interventions

Cortico-cortical paired associative stimulation

Two brain areas will be stimulated with transcranial magnetic stimulation pulses. The pulses will be delivered with a time difference, on other words, one pulse after another.

Sham cortico-cortical paired associative stimulation

Two brain areas will be stimulated with sham transcranial magnetic stimulation. The sham pulses will be delivered with a time difference, on other words, one pulse after another.

Primary outcome measure

  • Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI) [ Time Frame: Before vs. after ccPAS/sham ccPAS, on Days 1, 5, and 10 of the ccPAS/sham ccPAS regimen. We also compare the responses from Day 1 vs. Day 10. ]

Central Contacts and Locations

Central contacts

Laura Kinsey, MS, CCC-SLP

3122385691lkinsey@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Laura Kinsey, MS, CCC-SLP

3122385691lkinsey@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Dec 21, 2022

Last verified

Dec, 2022

Keywords

  • Transcranial Magnetic Stimulation
  • Stroke Aphasia
  • Language
  • Functional Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2022-12-21.