Brain network malleability by computerised cognitive training in attention deficit hyperactivity disorder
| ISRCTN | ISRCTN42801302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42801302 |
- Submission date
- 06/05/2024
- Registration date
- 09/05/2024
- Last edited
- 03/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Individuals with attention deficit hyperactivity disorder (ADHD) often face problems in executive functions, including visuospatial and verbal working memory. Cognitive training has been proposed as a candidate for ADHD rehabilitation, and previous studies have shown it can have positive effects on untrained working memory tasks and even on inhibition control and attention. It is less clear how cognitive training affects brain activity or structure in individuals with ADHD. This study aims to explore how working memory training affects the brain’s white matter structures and brain activation during working memory performance, rest, and movie watching in individuals with ADHD.
Who can participate?
Participants aged 18 to 63 years with ADHD
What does the study involve?
Adults with ADHD took part in a randomised controlled working memory trial, either training on a dual n-back working memory task or, as an active control, playing the Bejeweled 2 computer game. Participants in both groups trained for 5 weeks, thrice a week, for 25 minutes at a time. Neuropsychological assessment, other cognitive tasks, and functional and MRI scans were conducted before and after the training period.
What are the possible benefits and risks of participating?
Magnetic resonance imaging is a safe, non-invasive method, and due to careful pre-screening no harms were expected or experienced. Working memory training might in general have positive effects on ADHD symptoms and working memory deficits.
Where is the study run from?
1. Åbo Akademi University (Finland)
2. University of Helsinki (Finland)
3. Hospital District of Helsinki and Uusimaa (Finland)
When is the study starting and how long is it expected to run for?
January 2015 to February 2018
Who is funding the study?
1. Åbo Akademi University (Finland)
2. Research Council of Finland
Who is the main contact?
Tuija Tolonen, tuija.tolonen@helsinki.fi
Contact information
Principal Investigator
Tehtaankatu 2
Turku
20500
Finland
| Phone | N/A |
|---|---|
| matti.laine@abo.fi |
Scientific
Otakaari 3
Espoo
02150
Finland
| Phone | N/A |
|---|---|
| juha.salmitaival@aalto.fi |
Public
Haartmaninkatu 3
Helsinki
00290
Finland
| Phone | N/A |
|---|---|
| tuija.tolonen@helsinki.fi |
Study information
| Study design | Double-blind randomized controlled single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Laboratory, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial to examine the effects of computerised working memory training on brain activity and structural and functional connectivity in adults with attention deficit hyperactivity disorder |
| Study acronym | ADHD-Train |
| Study objectives | Due to its exploratory nature, this study is based on study questions, rather than hypotheses: 1. Does working memory training affect regional brain activation during working memory performance, rest, or movie watching? 2. Does working memory training affect temporal brain activity correlations between brain areas during working memory performance, rest, or movie watching? 3. Does working memory training affect white matter microstructure or connectivity? |
| Ethics approval(s) |
Approved 30/06/2015, Ethics Committee for Gynecology and Obstetrics, Pediatrics and Psychiatry of the Helsinki and Uusimaa Hospital District (Tukholmankatu 8 C, Helsinki, 00290, Finland; +358 (0)40 359 4618; eettiset.toimikunnat@hus.fi), ref: HUS/1166/2021 |
| Health condition(s) or problem(s) studied | Attention deficit hyperactivity disorder |
| Intervention | After a pretest including neuropsychological assignment, cognitive tasks, and magnetic resonance imaging, the participants were assigned to an experimental group (performing dual n-back working memory task) or an active control group (playing Bejeweled 2 computer game) with simple randomisation using an equal amount of lottery tickets per group. Each participant in both groups trained for 5 weeks, three times a week, 25 minutes at a time, adding up to total of 15 training sessions. A post-test with the same elements as the pretest was conducted after the cognitive training. The participants were blind to whether they belonged to the experimental or the control group, as was the experimenter conducting the pre- and post-tests. |
| Intervention type | Behavioural |
| Primary outcome measure | Blood oxygen level dependent (BOLD) signal in the brain measured by functional magnetic resonance imaging during the pretest (within few weeks before the cognitive training) and the posttest (within few weeks after the cognitive training). Due to the study’s experimental design, BOLD signal is assessed in different conditions (during working memory task, rest, and movie watching) and can be analysed in several ways, including regional activity and their temporal correlations. |
| Secondary outcome measures | White matter properties of the brain measured by diffusion-weighted magnetic resonance imaging during the pretest (within a few weeks before the cognitive training) and the posttest (within a few weeks after the cognitive training). White matter properties can be analysed in several ways, including microstructure and tractography. |
| Overall study start date | 01/01/2015 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 63 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Age between 18 and 63 years 2. Diagnosed with attention deficit hyperactivity disorder according to DSM-IV by a specialised doctor 3. Excellent competency in Finnish 4. Sufficient vision and hearing |
| Key exclusion criteria | 1. History of brain damage 2. Other severe neurological or psychiatric disorders apart from ADHD, including substance abuse or other addictions 3. IQ lower than 70 assessed by the Wechsler Adult Intelligence Scale III 4. Magnetic resonance imaging contraindications |
| Date of first enrolment | 01/08/2015 |
| Date of final enrolment | 31/01/2018 |
Locations
Countries of recruitment
- Finland
Study participating centres
Helsinki
00170
Finland
Espoo
02150
Finland
Sponsor information
University/education
Tuomiokirkontori 3
Turku
20500
Finland
| Phone | +358 (0)221531 |
|---|---|
| fhpt@abo.fi | |
| Website | https://www.abo.fi |
"ROR" |
https://ror.org/029pk6x14 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- ÅA
- Location
- Finland
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Results and Publications
| Intention to publish date | 19/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | One study of this trial has already been published in Human Brain Mapping (https://pubmed.ncbi.nlm.nih.gov/32813290/). Future studies will be published in high-impact peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the details in the ethical agreement for the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/08/2020 | 07/05/2024 | Yes | No | |
| Results article | Working memory related functional connectivity | 02/11/2024 | 03/07/2025 | Yes | No |
Editorial Notes
03/07/2025: Publication reference added.
07/05/2024: Study's existence confirmed by the Hospital District of Helsinki and Uusimaa Research Ethics Committee.
