Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/10/2020
Date assigned
15/10/2020
Last edited
14/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
After a traumatic brain injury, disturbances in the attentional processes have a direct negative effect on functional recovery and on return to complex activities. To date, there is no good attention remediation treatment available. Transcranial direct current stimulation (tDCS) involves constant, low direct current being delivered via electrodes on the head. The aim of this study is to assess the feasibility of using tDCS to improve attention disorders in patients with mild complicated to severe subacute traumatic brain injury, hospitalized in an inpatient rehabilitation facility.

Who can participate?
Male and female over 18 years old with attention disorders after a mild complicated to severe subacute traumatic brain injury

What does the study involve?
All participants will receive a 20-minute tDCS stimulation three times a week for 3 weeks. An evaluation will be performed before and after the intervention. Participant characteristics, as well as information about satisfaction, tolerability and adverse effects, will be collected.

What are the possible benefits and risks of participating?
Participants will possibly improve their attention with the proposed intervention. Possible side effects of tDCS are fatigue, pain, tingling, skin redness and a burning sensation. Seizures are the most concerning adverse events. If compensatory safety steps are taken, experts agree that the expected benefit justifies the increased risk.

Where is the study run from?
Institut universitaire sur la réadaptation en déficience physique de Montréal (Canada)

When is the study starting and how long is it expected to run for?
November 2017 to January 2020

Who is funding the study?
The Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR) (Canada)

Who is the main contact?
Dr Eve Boissonnault
eve.boissonnault@umontreal.ca

Trial website

Contact information

Type

Public

Primary contact

Dr Eve Boissonnault

ORCID ID

http://orcid.org/0000-0002-5994-2903

Contact details

Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
6300
avenue de Darlington (Pavillon Gingras)
Montreal
H3S 2J4
Canada
+1 (0)514 295 3395
eve.boissonnault@umontreal.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CRIR-1337-0518

Study information

Scientific title

Brain stimulation, an innovative approach for the treatment of attention deficits after traumatic brain injury during the inpatient phase of rehabilitation: a feasibility study

Acronym

Study hypothesis

It is hypothesized that anodal transcranial direct-current stimulation (tDCS) applied on the left DLPFC has the potential to enhance attention in patients with mild complicated to severe TBI.

Ethics approval

Approved 04/06/2018, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR) Research Ethics Board (6363, chemin Hudson, bureau 061, Pavillon Lindsay de l’IURDPM, Montréal QC H3S 1M9, Canada; +1 (0)514 340-2085 (4778); administration.crir@ssss.gouv.qc.ca), ref: CRIR-1337-0518)

Study design

Single-centre literature review and feasibility study

Primary study design

Interventional

Secondary study design

Non-controlled study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Attention deficits after traumatic brain injury

Intervention

Participants will receive the tDCS protocol, which consists of 20 minutes tDCS active stimulation three times a week for 3 weeks for a total of nine sessions. The tDCS will be applied by experienced researchers. The skin at the site of the electrodes will be cleaned with alcohol. Two saline-soaked electrodes of 25 cm² each (5 x 5 cm) will be placed on the scalp: an anode (excitatory electrode) overlying the left DLPFC, and a cathode (reference electrode) above the right supraorbital area. The electrodes will be inserted into 5 x 5 cm sponges soaked in saline and fixed with two elastic bands. tDCS will be delivered using a battery-driven tDCS stimulator (Model 1300A; Soterix Medical, New York, NY, USA). Current delivery will be monitored throughout the testing. Participants will undergo 20-minute sessions of tDCS at an intensity of 2 mA and a current density of 0,08 mA/cm². Participants will sit in a quiet room during stimulation and will be asked to remain inactive.

Intervention type

Device

Phase

Phase II

Drug names

Battery-driven tDCS stimulator (Model 1300A; Soterix Medical, New York, NY, USA)

Primary outcome measure

Tolerance, adverse effects and safety measured using a customized questionnaire adapted from those provided by Brunoni et al. at the end of each stimulation

Secondary outcome measures

1. Selective attention measured using the Test of Everyday Attention and the Stroop from the Delis-Kaplan Executive Function System at baseline and after the last stimulation session
2. Sustained and selective attention measured using the Ruff 2 &7 Selective Attention Test at baseline and after the last stimulation session
3. Visual sustained attention, vigilance, impulsivity and inattentiveness measured using the Conners Continuous Performance Test 3rd Edition at baseline and after the last stimulation session
4. Visual sustained attention, vigilance, impulsivity and inattentiveness measured using the Conners Continuous Performance Test 3rd Edition at baseline and after the last stimulation session
5. Working memory measured using the Digit Span subtest from the Wechsler adult intelligence scale–Fourth Edition (WAIS-IV) at baseline and after the last stimulation session
6. Processing speed measured using the Coding subtests from the WAIS-IV Edition at baseline and after the last stimulation session
7. Ability to analyze and synthesize abstract visual stimuli measured using the Block Design subtest from the WAIS-IV at baseline and after the last stimulation session

Overall trial start date

01/11/2017

Overall trial end date

01/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Current hospitalization
2. Age 18 years old or more
3. Diagnosis of mild complicated, moderate or severe TBI
4. Attentional impairment as per qualitative clinical assessment
5. French or English speaking
6. Tolerance to 45 to 60 minutes neuropsychology evaluation
7. Capacity to consent in accordance with the Nova Scotia Hospitals Act

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5

Total final enrolment

6

Participant exclusion criteria

1. History of neurological disease not resulting from the current TBI (e.g., stroke, multiple sclerosis, neurodegenerative disorders)
2. Psychiatric illness (e.g., depression, schizophrenia, anxiety disorders)
3. Aphasia and compromises in understanding instructions
4. Significant deafness or blindness
5. Contraindication to tDCS (e.g., seizure, extensive cranial vault lesion, pregnancy or breastfeeding, pacemaker, cochlear implants or cerebral metal implanted device or clip)
6. Scar or skull deformity at the site of electrodes placement
7. Epileptogenic medication
8. Penetrating TBI

Recruitment start date

01/09/2018

Recruitment end date

01/01/2020

Locations

Countries of recruitment

Canada

Trial participating centre

Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
6300, avenue de Darlington (Pavillon Gingras)
Montreal
H3S 2J4
Canada

Sponsor information

Organisation

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Sponsor details

6363
chemin Hudson
bureau 061
Pavillon Lindsay de l’IURDPM
Montreal
H3S 1M9
Canada
+1 (0)514 340 2085 (4778)
administration.crir@ssss.gouv.qc.ca

Sponsor type

Research organisation

Website

https://crir.ca/

Funders

Funder type

Research organisation

Funder name

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are available upon request from Ève Boissonnault (eve.boissonnault@umontreal.ca). The data is available already, since 24/03/2020. Original data on paper sheets will be kept by Johanne Higgins at the IURPDM, in a locked closet for a 5-year period. The anonymized data and statistical analysis will be kept by Ève Boissonnault in Excel spreadsheets for a 5-year period as well. The data will be destroyed afterwards. The anonymized data is available on reasonable request. It was specified in the consent form signed by every participant.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/10/2020: Trial's existence confirmed by the Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR) Research Ethics Board.