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Computerised Working Memory Training in Acquired Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010149
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST
Dalhousie University
Information provided by (Responsible Party):
University of Birmingham

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.


Condition or disease Intervention/treatment Phase
Acquired Brain Injury Device: Active tDCS Device: SHAM tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: The Impact of Concurrent Brain Stimulation and Working Memory Training on Cognitive Performance in Acquired Brain Injury
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Active tDCS
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
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).

Sham Comparator: SHAM tDCS
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
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).




Primary Outcome Measures :
  1. Changes in memory capacity, as measured by number of items that are memorised successfully, in the cognitive task used as the training regime; [ Time Frame: On day1, at end of week 2, at end of week 5 and at end of week 9 ]
    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.


Secondary Outcome Measures :
  1. Changes in memory capacity, as measured by number of items that are memorised successfully, in untrained cognitive tasks. [ Time Frame: On day1, at end of week 2, at end of week 5 and at end of week 9 ]
    Changes in the number of items memorised successfully are measured in a task different from the training task, but that tap into the same cognitive process (near transfer), or from a different task tapping into a different cognitive domain (mid transfer).

  2. Persistence of changes in memory capacity through time [ Time Frame: On day1, at end of week 2, at end of week 5 and at end of week 9 ]
    Maintenance of memory capacity changes after termination of the training, as measured by the memory capacity, i.e., number of items memorised successfully, at different time point during and a month after the completion of the intervention, with respect to day 1 of the intervention.


Other Outcome Measures:
  1. Impact of the intervention on self-reported everyday cognitive perfomrance, as measured by the PRECiS questionnaire. [ Time Frame: On day1, at end of week 2, at end of week 5 and at end of week 9 ]
    Impact of the intervention on self-reported everyday cognitive performance as measured by the Patient Reported Evaluation of Cognitive Status (PRECiS), taken at different time points along and after the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010149


Contacts
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Contact: Birgit Whitman, Dr 00441214147618 researchgovernance@contacts.bham.ac.uk
Contact: Kimron Shapiro +441214144930 k.l.shapiro@bham.ac.uk

Sponsors and Collaborators
University of Birmingham
NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST
Dalhousie University
Investigators
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Principal Investigator: Kimron Shapiro University of Birmingham
Publications:
Mameli, F., Fumagalli, M., Ferrucci, R., & Priori, A. (2014). The Stimulated Brain. PART III: IMPROVING FUNCTIONS IN THE ATYPICAL BRAIN, 371-395.
Conway, A. R., Jarrold, C., Kane, M. J., Miyake, A., & Towse, J. N. (2008). Variation in Working Memory, 3-18.

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04010149    
Other Study ID Numbers: RG_18-142
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
Working memory
cognitive training
tDCS
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System