Computerised Working Memory Training in Acquired Brain Injury

NCT04010149 | Unknown

• 1 other identifier: RG_18-142
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Working memory is a limited capacity cognitive system in which information is held temporarily in order to make it available for processing. The amount of information that can be held in mind varies considerably from person to person and changes across the lifespan. Working memory is frequently affected following brain injury. As working memory is important for cognitive skills such as problem solving, planning and active listening, a deficit in working memory can lead to difficulties with many everyday activities that are necessary for work, study and general functioning. Impaired working memory may consequently have a significant impact on a person's quality of life and ability to participate in previous social roles, with potential for effects on mood and emotional wellbeing. Evidence shows that non-invasive transcranial direct current brain stimulation (tDCS) can be used in combination with computerized memory training (CT) over multiple days, to enhance working memory in healthy and clinical populations. In patients with an acquired brain injury (ABI), cognitive training or brain stimulation have been used alone to improve attention or memory-related impairment, but the effect of the concurrent used of the two interventions over multiple days is yet to be investigated. With this research the investigators propose to investigate the effect of the combined use of tDCS and CT to improve memory performance in patients with acquired brain injury. The investigators propose to use a multi-day cognitive training regime to exercise working memory, while stimulating the brain with low intensity direct currents. Success will be measured as improvement in performance in several cognitive domain, before and after training.

Conditions

Acquired Brain Injury

Keywords

Working memory; cognitive training; tDCS

Outcome Measures

Primary Outcomes (1)

• Changes in memory capacity, as measured by number of items that are memorised successfully, in the cognitive task used as the training regime;

  The difficulty of the training regime is manipulated by increasing N, i.e. the number of items the participant is requested to memorise. As such, N is used to measure individual memory capacity. Changes in memory capacity, as the training regime progresses is the primary outcome measure of this study.

  On day1, at end of week 2, at end of week 5 and at end of week 9

Secondary Outcomes (2)

• Changes in memory capacity, as measured by number of items that are memorised successfully, in untrained cognitive tasks.

  On day1, at end of week 2, at end of week 5 and at end of week 9

• Persistence of changes in memory capacity through time

  On day1, at end of week 2, at end of week 5 and at end of week 9

Other Outcomes (1)

• Impact of the intervention on self-reported everyday cognitive perfomrance, as measured by the PRECiS questionnaire.

  On day1, at end of week 2, at end of week 5 and at end of week 9

Study Arms (2)

Active tDCS

EXPERIMENTAL

During cognitive training in the first 2 weeks, participants will also received brain stimulation. The investigators will use a total current intensity of 2mA for 20 minutes, preceded by 30 seconds ramping up and followed by 30 seconds ramping down (total stimulation time = 21s).

Device: Active tDCS

SHAM tDCS

SHAM COMPARATOR

During sham stimulation, concurrent with the cognitive training, The investigators will use the same setup as in the active condition but after ramping up, the current will be brought back to zero and the process repeated 30 seconds before the end of the 21 minutes time interval (total sham stimulation time = 21s).

Device: SHAM tDCS

Interventions

Active tDCS DEVICE

For the first two weeks of the study, participants will receive 20 min of brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).

Active tDCS

SHAM tDCS DEVICE

For the first two weeks of the study, participants will receive 20 min of SHAM brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).

SHAM tDCS

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to the service
• Are between 18 and 69 years of age
• Have capacity and able to provide informed consent
• Normal or corrected-to-normal vision and hearing
• Having a working memory impairment (see screening procedure below)
• At least three months between the injury and the starting of the study
• Has a computer or has access to a computer

You may not qualify if:

• Pre-injury psychiatric or neurological disease by self-report (e.g., anxiety disorder, ADHD, Parkinson's disease, etc.)
• History of diagnosed severe depression (diagnosed pre-injury)
• History of epilepsy (diagnosed pre-injury)
• Family history of epilepsy
• Have had fainting spells or syncope in the last three years pre-injury
• Have significant hearing loss, vision or motor impairment that would prevent them from performing the task
• Known to be pregnant
• Assuming medication affecting cortical excitability or recreational drugs
• Metal (except titanium) or electronic implants in the brain /skull (e.g., splinters, fragments, clips, cochlear implant, deep brain stimulation, medication pump…)
• Metal (except titanium) or any electronic device at other sites in the participant's body, such as cardiac pacemaker or traumatic metallic residual fragments
• Have skin problems such as dermatitis, psoriasis or eczema under the stimulation sites
• Have had brain stimulation in the past six months
• Have undergone transcranial electric or magnetic stimulation in the past (more than 6 months) which resulted in adverse effects
• Skull fractures, significant skull defects, skull plates or large vessels occlusions in the site of electrode placement
• having had a seizure at the time of accident or between the injury and starting of the therapy.

Sponsors & Collaborators

• University of Birmingham: lead
• Northamptonshire Healthcare NHS Foundation Trust: collaborator
• Dalhousie University: collaborator

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  PMID: 33243286 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kimron Shapiro

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Whitman, Dr

CONTACT

00441214147618; researchgovernance@contacts.bham.ac.uk

Kimron Shapiro

CONTACT

+441214144930; k.l.shapiro@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A computer programme will generate a random list assigning group allocation to participant numbers. The participant numbers will be given out in order of attendance in the laboratory. The study design is double blind: participants and the researchers who are conducting the behavioural testing will not know until the end of the intervention if the participant received brain stimulation. A researcher from the University of Birmingham (Dr Assecondi) will setup the blind protocol on the brain stimulation device and will keep a record of this.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will begin the administration of the baseline measures (T0), and outcome measures (T1). On the first training day, participants will receive active or sham brain stimulation, concurrent with one session of their training routine (20 minutes). Before each training session, participants will also be asked to answer short questions (level of alertness, engagement, etc.). Participants will complete 10 additional consecutive training sessions (2 weeks), at home. Each session should take about 45 minutes. When the first training phase is complete, the participant will undergo time 2 (T2) assessment, as in T1. Participants will then start the second training phase, involving 3 weeks of training only (no brain stimulation), at home. When the second training phase is completed, participants will undergo time 3 (T3) assessment, as in T2. A last follow-up assessment, as T3, will be carried out at T4, a month after the completion of the intervention.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 8, 2019
• Study Start: November 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 2, 2019

Record last verified: 2019-03