Effects of the Combination of RRT With tDCS on Dyslexic Adults

NCT ID: NCT03119402

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2018-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS) on reading abilities of a group of Italian undergraduate students with dyslexia. Two experimental conditions (active vs. sham) will be compared. Finally, the effects of the intervention on other cognitive functions involved in the process of reading (i.e., rapid automatized naming, verbal working memory, rhythm perception abilities) will be measured.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Developmental Dyslexia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are prevented from having knowledge of which experimental condition (active or sham tDCS) they are assigned to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RRT + active tDCS

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of active tDCS (1.5 mA, 5x5cm anodal electrode on left parieto-temporal regions and 5x5cm cathodal electrode on right parieto-temporal regions).

Group Type EXPERIMENTAL

Rhythmic Reading Training

Intervention Type BEHAVIORAL

RRT is a computerized reading training program designed for Italian students with dyslexia. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.

Transcranial direct current stimulation

Intervention Type DEVICE

tDCS (transcranial direct current stimulation) is a noninvasive weak-current brain stimulation technique that can facilitate (anodal electrode) or inhibit (cathodal electrode) cortical activity, thus offering exciting possibilities for the enhancement and treatment of impaired cognitive abilities.

RRT + sham tDCS

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of sham tDCS (with the same active tDCS setup, current applied for 30 seconds,

Group Type SHAM_COMPARATOR

Rhythmic Reading Training

Intervention Type BEHAVIORAL

RRT is a computerized reading training program designed for Italian students with dyslexia. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.

Transcranial direct current stimulation

Intervention Type DEVICE

tDCS (transcranial direct current stimulation) is a noninvasive weak-current brain stimulation technique that can facilitate (anodal electrode) or inhibit (cathodal electrode) cortical activity, thus offering exciting possibilities for the enhancement and treatment of impaired cognitive abilities.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rhythmic Reading Training

RRT is a computerized reading training program designed for Italian students with dyslexia. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.

Intervention Type BEHAVIORAL

Transcranial direct current stimulation

tDCS (transcranial direct current stimulation) is a noninvasive weak-current brain stimulation technique that can facilitate (anodal electrode) or inhibit (cathodal electrode) cortical activity, thus offering exciting possibilities for the enhancement and treatment of impaired cognitive abilities.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RRT tDCS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alice Cancer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Catholic University of the Sacred Heart

Milan, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alice Cancer, MD

Role: CONTACT

00390272342284

Alessandro Antonietti, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alice Cancer, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RRT+tDCS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neuromodulation in COVID-19 Patients
NCT04808284 COMPLETED PHASE1/PHASE2
TDCS-RTMS Intervention for Motor Function
NCT07257601 NOT_YET_RECRUITING NA