The effects of transcranial direct current stimulation on the brain electrical signal changes that happen to nicotine users: an exploratory study
| ISRCTN | ISRCTN70382365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70382365 |
| Secondary identifying numbers | MUM-RP-tDCSN-VER01-31JAN24 |
- Submission date
- 12/06/2024
- Registration date
- 26/06/2024
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Nicotine use disorder, also known as tobacco addiction, is a serious condition that can make it difficult to stop using tobacco products. This study investigates electrical changes in the brain under the influence of direct current brain stimulation (tDCS) to better understand the disorder's basis and provide alternative treatments. tDCS is known to have some benefits according to previous studies in rehabilitation medicine, post-stroke movement disorders, nerve studies and other substance disorders.
Who can participate?
People aged 18-55 years with nicotine use disorder
What does the study involve?
Participants will receive tDCS intervention lasting 20 minutes per session. These sessions will occur 5 days a week, spanning 2 weeks. Participants undergo an electroencephalogram (EEG) recording at 6 weeks.
What are the possible benefits and risks of participating?
There are no direct benefits to participants. However, participation might help to improve our understanding of nicotine use disorder and provide better treatment in the future. The device used is simple and safe. No invasive procedures are involved as the device is applied across the head surface without creating any wounds. There might be an unpleasant tingling sensation, headache, itchiness, or burning sensation during the procedure due to the placement of electrodes.
Where is the study run from?
Hospital Permai (Malaysia)
When is the study starting and how long is it expected to run for?
January 2024 to December 2024
Who is funding the study?
Monash University (Malaysia)
Who is the main contact?
Dr Yee Hway Ann @ Anne Yee, anne.yee@monash.edu
Contact information
Public, Scientific, Principal Investigator
Jeffrey Cheah Sch of Med & HS
Monash University Malaysia
Johore Bahru
80100
Malaysia
 ORCID ID |
0000-0002-9835-6798 |
|---|---|
| Phone | +60 (0)198891360 |
| anne.yee@monash.edu |
Study information
| Study design | This exploratory research (involve intervention) is focused on examining the impact of transcranial Direct Current Stimulation (tDCS) on subjects diagnosed with nicotine use disorder. The study primarily utilizes Electroencephalography (EEG) to monitor and analyze changes in cortical activities resulting from the tDCS intervention. The objective is to understand how tDCS influences brain function in individuals affected by nicotine dependence. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 45611_PIS_31Jan24.pdf |
| Scientific title | The effects of transcranial direct current stimulation on EEG changes in nicotine use disorder patients: an exploratory study |
| Study acronym | tDCSN |
| Study objectives | 1. There are EEG changes (alpha, beta delta and theta wave at different regions, including the prefrontal lateral lobe) before and after transcranial direct current stimulation (tDCS) in nicotine use disorder patients. 2. There is efficacy of tDCS in the treatment of nicotine withdrawal. |
| Ethics approval(s) |
1. Approved 17/07/2024, National Institute of Health, Malaysia (Jalan Setia Murni U13/52, Seksyen U13 Setia Alam, Shah Alam, 40170, Malaysia; +60 (0)3 3362 8888; mrecsec@moh.gov.my), ref: RSCH-ID-24-01102-QTS 2. Approved 17/07/2024, Monash University Human Research Ethics Committee (MUHREC) (Monash Human Ethics Office, Wellington Road, Clayton, Victoria, 3800, Australia; +61 (0)3 990 51478; lauren.morris@monash.edu), ref: 44302 |
| Health condition(s) or problem(s) studied | Nicotine use disorder |
| Intervention | Transcranial Direct Current Stimulation (tDCS). Participants will receive tDCS intervention lasting 20 minutes per session. These sessions will occur 5 days a week, spanning 2 weeks. The tDCS will be delivered following standardized protocols to ensure safety and uniformity across treatments. There is no control group, hence, no randomisation is required. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcranial direct current stimulation device |
| Primary outcome measure | EEG is measured using the standard 64-channel EEG machine at baseline (T0), week 1 (T1) and week 6 (T6) |
| Secondary outcome measures | 1. Nicotine dependence assessed using the Fagerstrom Test for Nicotine Dependence (FTND) at baseline (T0), week 1 (T1) and week 6 (T6) 2. Withdrawal symptoms assessed using the Minnesota Nicotine Withdrawal Scale (MNWS) at baseline (T0), week 1 (T1) and week 6 (T6) |
| Overall study start date | 31/01/2024 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Aged 18-55 years 2. Diagnosed with nicotine use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 3. Healthy with no history of seizure, epilepsy, head trauma, or head surgery |
| Key exclusion criteria | 1. Concomitant psychiatric disorder 2. Polysubstance disorder/uses 3. On psychotropic treatment |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 01/12/2024 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Johor Bahru
81200
Malaysia
Sponsor information
University/education
No. 8, Masjid Sultan Abu Bakar
Johor
80100
Malaysia
| Phone | +60 (0)35514 6000 |
|---|---|
| mum.business.research@monash.edu | |
| Website | https://www.monash.edu.my/ |
"ROR" |
https://ror.org/00yncr324 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Jeffrey Cheah School of Medicine & Health Sciences, Jeffrey Cheah School of Medicine and Health Sciences, JCSMHS
- Location
- Malaysia
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets will be stored in a non-publicly available repository, however, other authors can request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 31/01/2024 | 20/06/2024 | No | Yes | |
| Protocol file | 31/01/2024 | 20/06/2024 | No | No |
Additional files
Editorial Notes
17/12/2024: The overall end date was changed from 30/04/2025 to 31/12/2024.
06/11/2024: The recruitment end date was changed from 01/11/2024 to 01/12/2024.
14/08/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 01/08/2024 to 01/10/2024.
3. The recruitment end date was changed from 30/09/2024 to 01/11/2024.
09/08/2024: Ethics approval details added.
03/07/2024: The recruitment start date was changed from 01/07/2024 to 01/08/2024.
20/06/2024: Study's existence confirmed by Monash University Malaysia.
