Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404890252448 Date of Registration: 10/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A pilot trial of feasibility, acceptability, tolerability, and efficacy of accelerated bilateral theta burst repetitive transcranial magnetic stimulation treatment for MDD in people with HIV in South Africa
Official scientific title A pilot pre- post trial of the feasibility, acceptability, tolerability, and efficacy of accelerated bilateral theta-burst stimulation for depression in adults with HIV in South Africa
Brief summary describing the background and objectives of the trial Recognition and the availability of repetitive transcranial magnetic stimulation (rTMS)/theta-burst stimulation (TBS) treatment, as a valuable, non-invasive, tolerable, and safe treatment modality for psychiatric patients is increasing. However, it has not been evaluated in the treatment of major depressive disorder (MDD) in the people with HIV (PWH) population specifically. One study evaluated the use of transcranial direct current stimulation (a neuromodulation technique that uses constant, low direct current delivered via electrodes on the head) for MDD in PWH and reported substantial depressive symptom improvement and good tolerability. rTMS/TBS treatment is a potentially useful treatment alternative for comorbid MDD in the PWH population. Its availability in South Africa holds immense potential to improve MDD, cognition, and consequent functional outcomes for PWH. However, before advocating for its clinical use in this population, this treatment modality's feasibility, acceptability, tolerability, and efficacy must be demonstrated. Therefore, the overarching aim of the proposed pilot study is to evaluate the feasibility, acceptability, tolerability, and preliminary efficacy of an accelerated bilateral TBS protocol for comorbid MDD in adults with HIV in the Western Cape, South Africa. To meet this aim, we propose four specific objectives: (i) Evaluate the feasibility, acceptability, and tolerability of an accelerated bilateral TBS treatment protocol for comorbid MDD in PWH (ii) Evaluate the preliminary efficacy of an accelerated bilateral TBS protocol on change in cognitive function pre- to post-treatment, and longitudinal follow-up. (iii) Evaluate the preliminary efficacy of an accelerated bilateral TBS protocol on change in cognitive function pre- to post-treatment, and longitudinal follow-up. (iv) Gain a better understanding of participants’ experience of accelerated bilateral TBS as a treatment modality in our setting.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 08/04/2024
Actual trial start date 08/04/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral TBS treatment This study will be a single-arm open-label pilot pre-post trial of an eight-day accelerated bilateral TBS treatment protocol of 20 sessions targeting comorbid MDD in PWH. This study will be a single-arm open-label pilot pre-post trial of an eight-day accelerated bilateral TBS treatment protocol of 20 sessions targeting comorbid MDD in PWH Over the eight treatment visits (which will occur within two weeks), participants will receive 20 accelerated bilateral TBS sessions targeting MDD. Intermittent TBS (iTBS) will be delivered to the left DLPFC, and continuous TBS (cTBS) will be delivered to the right DLPFC for two minutes. This bilateral protocol (one iTBS and one cTBS session) will be accelerated from one session on the first day to two sessions on days two and three, aiming to administer three sessions per day from day four onward. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults (≥ 18 years) diagnosed with HIV On ART for an uninterrupted period of at least six months Current comorbid MDD diagnosis confirmed by a diagnostic interview. Able to attend the treatment and monitoring visits at the university campus during office hours. Able to provide written informed consent. For participants on psychotropic medication, a stable dose (≥2 months) will be required before the pre-treatment assessment. These participants will continue with their current treatment regimens for the duration of their trial participation. Participants will also be required not to engage in other interventions (i.e., psychotherapy) during the study period (six weeks from pre-treatment to one-month follow-up). Pregnant Known with life-threatening medical illnesses (e.g., cancer), or serious psychiatric conditions (e.g., psychosis, mania). Participants with specific TMS-associated contraindications (e.g., metal implants close to the skull area or uncontrolled epilepsy) will also be excluded. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/01/2024 Health and Research Ethics Comittee HREC
Ethics Committee Address
Street address City Postal code Country
Franci van Zijl Drive Tygerberg 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recruitment and study enrolment rate, attrition rate, reported adverse events, and participant’s self-reported perceptions. Time 1 - pre-treatment. Time 2 - after 11 sessions, Time 3 - after 20 sessions, Time 4 - one month follow-up
Primary Outcome Change in Hamilton Rating Scale for Depression (HAM-D) 17-item total scores from pre- to post-treatment (Time 1 – 3). Time 1 - pre-treatment. Time 2 - after 11 sessions, Time 3 - after 20 sessions.
Primary Outcome Change in Montreal Cognitive Assessment (MoCA) total scores from pre- to post-treatment (Time 1 – 3). Time 1 - pre-treatment. Time 2 - after 11 sessions, Time 3 - after 20 sessions, Time 4 - one month follow-up
Secondary Outcome Change in HAM-D (17-item) total score from pre-treatment and longitudinal follow-up (Time 1 - 4). Change in self-reported depressive symptoms on the Beck's Depression Inventory (BDI) 21-item total score from pre- to post-treatment (Time 1 – 3). Change in BDI (21-item) score from pre-treatment and longitudinal follow-up (Time 1- 4) Time 1 - pre-treatment. Time 2 - after 11 sessions, Time 3 - after 20 sessions, Time 4 - one month follow-up
Secondary Outcome Change in MoCA score from pre-treatment and longitudinal follow-up (Time 1- 4). Time 1 - pre-treatment. Time 2 - after 11 sessions, Time 3 - after 20 sessions, Time 4 - one month follow-up
Secondary Outcome Evaluation of participant experiences of this treatment modality, including tolerability, by reviewing detailed treatment folder notes and qualitative sub-study (answers to a semi-structured questionnaire). Time 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine and Health Sciences University Campus Franci van Zijl Drive Tygerberg 7500 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center of the National Institutes of Health 31 Center Drive Bethesda MD20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine and Health Sciences Franci van Zijl Drive Tygerberg 7500 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Erine Brocker erineb@sun.ac.za +270219389587 Franci van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Faculty of Medicine and Health Sciences Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Erine Brocker erineb@sun.ac.za 27219380587 Franci van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7500 South Africa Faculty of Medicine and Health Sciences Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Erine Brocker erineb@sun.ac.za +27219389587 Franci van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg South Africa Faculty of Medicine and Health Sciences Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Upon publishing the results of the study, we will include de-identified individual participant data that underlie the results (e.g., text, tables, figures, and appendices). We will also update the clinical trial register with a summary of the key results. Informed Consent Form,Study Protocol Immediately following publication. Results of this study will be published, and de-identified source data (including IPD) will be made available upon reasonable request from the primary investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information