NCT05572385

Brief Summary

In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

October 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

October 4, 2022

Last Update Submit

October 6, 2022

Conditions

Aphasia, Acquired

Outcome Measures

Primary Outcomes (1)

  • EEG correlates of language reconstitution

    Identitification of EEG features (N400, P600, Theta band activity) that correlate with clinical outcome of language reconstitution.

    3-6 months after stroke

Study Arms (2)

Patients with aphasia

ACTIVE COMPARATOR

Patients with a clinical aphasia (20 receptive, 20 expressive) with a specific logopedic treatment, with specific EEG measurement at start and end of treatment schedule.

Behavioral: CIAT + Conventional neurorehabilitative therapy

Patients without aphasia

NO INTERVENTION

Patients with comparable stroke characteristics, but without clinical aphasia.

Interventions

CIAT + Conventional neurorehabilitative therapyBEHAVIORAL

CIAT = Constrained induced aphasia therapy

Also known as: Conventional neurorehabilitative therapy
Patients with aphasia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a cerebrovascular event

You may not qualify if:

  • premorbid brain disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Dept. Clinical and Cognitive Neurorehabilitation

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 7, 2022

Study Start

July 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share