NCT02698449

Brief Summary

The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

6.4 years

First QC Date

February 18, 2016

Last Update Submit

March 29, 2023

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).

    12 weeks

Secondary Outcomes (5)

  • Intergroup differences in resting activation maps.

    12 weeks

  • Intergroup differences in diffusion measures

    12 weeks

  • Intergroup differences in neuropsychological score

    12 weeks

  • Correlation between activation extend and attentional outcomes

    12 weeks

  • Intergroup differences in polymorphisms

    12 weeks

Study Arms (4)

cognitive rehabilitation + transcranial stimulation

EXPERIMENTAL

specific cognitive rehabilitation combined to transcranial direct current stimulation

Procedure: transcranial direct current stimulationProcedure: Specific cognitive rehabilitationRadiation: functional Magnetic Resonance Imaging n-back task

cognitive rehabilitation + stimulation sham

EXPERIMENTAL

specific cognitive rehabilitation combined to transcranial direct current stimulation sham

Procedure: Specific cognitive rehabilitationProcedure: transcranial direct current stimulation shamRadiation: functional Magnetic Resonance Imaging n-back task

placebo rehab + transcranial stimulation

EXPERIMENTAL

nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation

Procedure: transcranial direct current stimulationProcedure: Nonspecific cognitive rehabilitationRadiation: functional Magnetic Resonance Imaging n-back task

placebo rehab + stimulation sham

EXPERIMENTAL

nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham

Procedure: Nonspecific cognitive rehabilitationProcedure: transcranial direct current stimulation shamRadiation: functional Magnetic Resonance Imaging n-back task

Interventions

transcranial direct current stimulationPROCEDURE

intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.

cognitive rehabilitation + transcranial stimulationplacebo rehab + transcranial stimulation
Specific cognitive rehabilitationPROCEDURE

Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.

cognitive rehabilitation + stimulation shamcognitive rehabilitation + transcranial stimulation
Nonspecific cognitive rehabilitationPROCEDURE

Nonspecific cognitive rehabilitation will be focused on representation of body in space.

placebo rehab + stimulation shamplacebo rehab + transcranial stimulation
transcranial direct current stimulation shamPROCEDURE

the same operation that transcranial direct current stimulating but it is a sham surgery

cognitive rehabilitation + stimulation shamplacebo rehab + stimulation sham
functional Magnetic Resonance Imaging n-back taskRADIATION

the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.

cognitive rehabilitation + stimulation shamcognitive rehabilitation + transcranial stimulationplacebo rehab + stimulation shamplacebo rehab + transcranial stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Moderate to severe traumatic brain injury
  • more than 3 months since the onset
  • Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation)
  • Women having contraceptive treatment (for the magnetic resonance imaging exam)

You may not qualify if:

  • inability to undergo magnetic resonance imaging scan
  • No attentional impairment (PASAT ≥ centile10)
  • Severe depression
  • Neurological disease
  • Major cognitive impairment (aphasia, neglect)
  • Drugs addiction
  • Pregnant women and women having no contraceptive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jérémie Pariente, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie Pariente, PhD

CONTACT

(0)5.61.77.95.02pariente.j@chu-toulouse.fr

Emilie Rigal, MD

CONTACT

(0)5.61.77.57.25rigal.e@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 3, 2016

Study Start

January 24, 2017

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)