NCT06974279

Brief Summary

The investigator proposes to examine the effects of excitatory transcranial magnetic stimulation (TMS) combined with semantic feature analysis (SFA) language therapy to improve word-finding abilities in stroke survivors with aphasia (SWA).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
130mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress6%
Sep 2025Dec 2036

First Submitted

Initial submission to the registry

February 17, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

11.3 years

First QC Date

February 17, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

AphasiaStrokeLanguageTMS

Outcome Measures

Primary Outcomes (1)

  • Accuracy on a picture naming test

    Changes in accuracy on untrained stimuli after SFA+TMS compared between groups (precision, control).

    immediately after and 8-12 weeks after last SFA+TMS treatment

Study Arms (2)

Precision TMS

ACTIVE COMPARATOR

SFA will be administered immediately after precision TMS

Device: Precision TMS with SFA

Control TMS

PLACEBO COMPARATOR

SFA will be administered immediately after control TMS

Device: Control TMS with SFA

Interventions

Excitatory TMS delivered using a precision site finding approach and intermittent theta burst stimulation protocol

Precision TMS

Excitatory TMS using intermittent theta burst stimulation delivered to a control vertex site.

Control TMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with left hemisphere stroke
  • Consent date \>= 1 month after stroke onset
  • Fluent in English
  • years of age or older

You may not qualify if:

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
  • A chronic medical condition that is not treated or is unstable
  • The presence of cardiac stimulators or pacemakers or intracardiac lines, neurostimulators, medication infusion device, any other implants near the scalp (e.g., cochlear implants) or in the eye, metal in the body (e.g., splinters, fragments, clips)
  • Pregnancy
  • History of skull fractures, or skin diseases
  • History of ongoing or unmanaged seizures
  • Presence of factors that potentially decrease seizure thresholds: on pro-convulsant medications, untreated sleep deprivation or insomnia, ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
  • History of dyslexia or other developmental learning disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (34)

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    BACKGROUND
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  • Abo M, Kakuda W, Watanabe M, Morooka A, Kawakami K, Senoo A. Effectiveness of low-frequency rTMS and intensive speech therapy in poststroke patients with aphasia: a pilot study based on evaluation by fMRI in relation to type of aphasia. Eur Neurol. 2012;68(4):199-208. doi: 10.1159/000338773. Epub 2012 Aug 29.

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MeSH Terms

Conditions

AphasiaStrokeLanguage

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesCommunicationBehavior

Central Study Contacts

Sidney Schoenrock, MA

CONTACT

Ari Hjelmeseth

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2025

First Posted

May 15, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2036

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations