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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05788042




Registration number
NCT05788042
Ethics application status
Date submitted
21/02/2023
Date registered
28/03/2023
Date last updated
7/08/2023

Titles & IDs
Public title
Trial of Enhanced Neurostimulation for Anorexia
Scientific title
Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
Secondary ID [1] 0 0
2021-016
Universal Trial Number (UTN)
Trial acronym
TRENA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Eating disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - MagPro TMS device (ARTG: 204659)
Treatment: Devices - tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)

Active comparator: Active transcranial Direct Current Stimulation (tDCS) - It will be given continuously for 30 minutes at 2 mA, twice daily (separated by \>=2 hours) over the first 4 weeks, and daily over the second 4 weeks of the 8 week acute treatment period (84 sessions total).

Sham comparator: Sham transcranial Direct Current Stimulation (tDCS) - It will involve an initial ramping up to 0.5 mA and then a ramp down to 0 mA for the remainder of each treatment. The same number of sessions as active tDCS will be administered.

Active comparator: Active Repetitive Transcranial Magnetic Stimulation (rTMS) - Active rTMS twice per day (separated by = 2 hours) over the first 4 weeks. Two sessions per day (separated by = 2 hours), given on 2 days each week for the following 4 weeks. The total number of rTMS sessions over the 8 week acute treatment period will be 56.

Sham comparator: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) - Sham rTMS twice per day (separated by = 2 hours) over the first 4 weeks. Two sessions per day (separated by = 2 hours), given on 2 days each week for the following 4 weeks. The same number of sessions as active rTMS will be administered.


Treatment: Devices: MagPro TMS device (ARTG: 204659)
rTMS will be administered using a MagPro TMS device (ARTG: 204659) which is approved for its intended use in this trial. rTMS involves the application of transient magnetic pulses which induce small currents in the underlying cortex via the principal of electromagnetic induction. rTMS will be administered using a patterned frequency stimulus called intermittent theta-burst stimulation (iTBS).This form of rTMS was chosen because a recent large multicentre trial showed 3 minutes of iTBS attained the same therapeutic effect as 30 minutes of standard rTMS, leading to FDA approval for depression. Each treatment session will comprise an extended iTBS session, i.e., 6.6 mins, delivered at 100% resting motor threshold (RMT). It will be targeted to the left DLPFC (F3 using the 10-20 International EEG system), consistent with the prior RCT of rTMS for AN.

Treatment: Devices: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
tDCS will be self-administered using the 1x1 tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) with two saline-soaked sponge electrodes held in place on the scalp using the Soterix Ole-2 headband. The device is intended to treat different neurological and psychiatric disorders. tDCS involves the passing of weak electrical current through the brain via electrodes placed upon the scalp. The current modulates the resting membrane potential of stimulated neurons which causes changes in neuronal excitability. The anode will be placed over the left F3 (10-20 System) and the cathode over F4 (electrode sizes 5 x 5cm, 25cm2). This montage was chosen to target the left DLPFC, consistent with prior pilot studies of tDCS in AN.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
Timepoint [1] 0 0
Change from baseline at 8 weeks
Primary outcome [2] 0 0
Acceptability
Timepoint [2] 0 0
8 weeks
Secondary outcome [1] 0 0
Weight
Timepoint [1] 0 0
Change from baseline at 4 weeks
Secondary outcome [2] 0 0
Weight
Timepoint [2] 0 0
Change from baseline at 8 weeks
Secondary outcome [3] 0 0
Weight
Timepoint [3] 0 0
Change from baseline at 20 weeks
Secondary outcome [4] 0 0
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Timepoint [4] 0 0
Change from baseline at 4 weeks
Secondary outcome [5] 0 0
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Timepoint [5] 0 0
Change from baseline at 8 weeks
Secondary outcome [6] 0 0
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Timepoint [6] 0 0
Change from baseline at 20 weeks
Secondary outcome [7] 0 0
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Timepoint [7] 0 0
Change from baseline at 8 weeks
Secondary outcome [8] 0 0
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Timepoint [8] 0 0
Change from baseline at 20 weeks
Secondary outcome [9] 0 0
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
Timepoint [9] 0 0
Change from baseline at 8 weeks
Secondary outcome [10] 0 0
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
Timepoint [10] 0 0
Change from baseline at 20 weeks
Secondary outcome [11] 0 0
Neurocognition - STROOP Colour Word Test (response inhibition).
Timepoint [11] 0 0
Change from baseline at 8 weeks
Secondary outcome [12] 0 0
Neurocognition - STROOP Colour Word Test (response inhibition).
Timepoint [12] 0 0
Change from baseline at 20 weeks
Secondary outcome [13] 0 0
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
Timepoint [13] 0 0
Change from baseline at 8 weeks
Secondary outcome [14] 0 0
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
Timepoint [14] 0 0
Change from baseline at 20 weeks
Secondary outcome [15] 0 0
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Timepoint [15] 0 0
Change from baseline at 8 weeks
Secondary outcome [16] 0 0
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Timepoint [16] 0 0
Change from baseline at 20 weeks
Secondary outcome [17] 0 0
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Timepoint [17] 0 0
Change from baseline at 8 weeks
Secondary outcome [18] 0 0
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Timepoint [18] 0 0
Change from baseline at 20 weeks
Secondary outcome [19] 0 0
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Timepoint [19] 0 0
Change from baseline at 8 weeks
Secondary outcome [20] 0 0
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Timepoint [20] 0 0
Change from baseline at 20 weeks
Secondary outcome [21] 0 0
Total cost of costs of rTMS and tDCS administration
Timepoint [21] 0 0
Through study completion, an average of 20 weeks
Secondary outcome [22] 0 0
Duration of inpatient hospital stay as recorded by clinical staff
Timepoint [22] 0 0
Through study completion, an average of 20 weeks
Secondary outcome [23] 0 0
Number of re-admissions as reported by clinical staff.
Timepoint [23] 0 0
From date of randomization until the date of study completion, assessed up to 20 weeks.
Secondary outcome [24] 0 0
Number of psychology sessions
Timepoint [24] 0 0
Through study completion, an average of 20 weeks
Secondary outcome [25] 0 0
Cost of psychology sessions
Timepoint [25] 0 0
Through study completion, an average of 20 weeks

Eligibility
Key inclusion criteria
* Aged =16 years,
* A current Diagnostic and Statistical Manual of Mental Disorders (5th edition DSM-5) diagnosis of anorexia nervosa
* Willing and able to participate and comply with study requirements
* Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing)
* Under ongoing care by his/her own treating psychiatrist (to ensure patient safety during the study)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to provide informed consent
* Contraindications to tDCS/rTMS
* Failed to respond to an adequate course or rTMS (4 weeks) within the current illness course
* Had ECT in the last 3 months
* MoCA score of <26
* Significant risk of significant self harm or suicide as assessed by study psychiatrist(s)
* Currently enrolled in another interventional clinical trial or using an investigational device/product

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northside Clinic - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months).

Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities.

Participants will be recruited and treated at one inpatient setting (Northside Clinic, St Leonards, Sydney). This facility is one of the largest specialist eating disorder settings in Australia with approximately 130 new admissions every year (2019 data). All participants who give consent and who fulfill the eligibility criteria will be randomised to receive active tDCS, sham (placebo) tDCS, active rTMS or sham rTMS over 8 weeks. Trial participants, their treating psychiatrist, ward staff, and a study staff member (who will conduct blinded assessments of mood secondary outcome measures) will be blinded after assignment to intervention until the database is locked and the primary analysis completed. All participants will complete assessments of eating disorder symptoms, mood, psychological symptoms, neurocognition and functioning at baseline, end of week 4, 8 and 20.

Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS). The investigators expect that both active treatment arms will produce clinical benefits and have high acceptability, and that clinical benefits will be maintained with long-term at-home tDCS continuation treatment. These outcomes have potential to assist in reducing hospital stay and emergency re-admissions and improving day to day functioning in participants. Health economic data for both treatment modalities will additionally have utility from a service perspective, given the disparity in resource requirements between the two treatments (TMS, tDCS) in terms of costs for patients and access to treatment for people living in remote and rural areas (i.e., for at-home tDCS).
Trial website
https://clinicaltrials.gov/study/NCT05788042
Trial related presentations / publications
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Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10.
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Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534.
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Public notes

Contacts
Principal investigator
Name 0 0
Sloane Madden, Assoc. Prof.
Address 0 0
University of Sydney, Ramsay Health Care
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Donel Martin, Dr
Address 0 0
Country 0 0
Phone 0 0
02 9382 8353
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05788042