Recruiting

Theta Burst Stimulation

Sponsor:

Ontario Shores Centre for Mental Health Sciences

Code:

NCT06323486

Conditions

Depressive Disorder, Treatment-Resistant

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

active accelerated bilateral sequential theta burst stimulation and sham treatment

Study Details

Brief summary:

The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future.

Conditions

Depressive Disorder, Treatment-Resistant

Study ID

NCT06323486

Start date

Apr 1, 2024

Status verified date

Mar, 2024

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Aged 50 years or older;
2. Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of a non-psychotic major depressive disorder;
3. Currently in a major depressive episode with a score on HAMD-17 of 17 or more;
4. Insufficient response (i.e., failure to achieve remission) to at least two appropriate courses of antidepressant medications during the current depressive episode (i.e., meeting the criteria for TRD);
5. Participants taking or not taking any psychotropic medication/s. If the eligible participant is on any psychotropic medications, the participant should have taken the medication/s at a stable dose for at least 1 week before the start of study intervention treatment and be willing to remain on a stable dose throughout the study follow-up;
6. Passing the TMS safety screen; and
7. Those who have the capacity to provide consent and who voluntary consent to participate in the study.

Exclusion Criteria

1. Those with MINI-confirmed active substance use disorder within the last 3 months;
2. Those with lifetime MINI-confirmed diagnosis of bipolar I disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder;
3. Those with major unstable medical comorbidities (i.e., rapidly deteriorating medical/neurological conditions that poses a significant risk to a person's life);
4. Those with a diagnosis of dementia confirmed using the Global Clinical Dementia Rating (CDR) with a score greater than or equal to 1.
5. Those with significant neurological conditions, such as those with any disease process associated with increased intracranial pressure, space-occupying intracranial lesion, history of epilepsy/seizure except those induced by ECT, or febrile seizure of infancy or a single occurrence of seizure associated with a known drug, cerebral aneurysm, or major head trauma resulting to loss of consciousness more than 5 minutes;
6. Those with cardiac pacemaker or implanted mediation pump;
7. Those with intracranial implants/hardwares, including but not limited to aneurysm clips, shunts, stimulators, cochlear implants, electrodes, or any other metal material inside or near the head (excluding the mouth) that cannot be safely removed;
8. Those who are taking more than 2 mg of Lorazepam daily (or equivalent) or taking any dose of an anticonvulsant that may potentially hamper rTMS efficacy;
9. Those who are unable to express and understand using the English language; and
10. Individuals who are pregnant or who are likely pregnant.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: absTBS-sham treatment sequence arm

Those assigned to the accelerated bilateral sequential theta burst stimulation (absTBS)-sham arm shall receive the blinded active absTBS treatment at Week 1. At Week 3, they shall receive the blinded sham treatment.

other: Sham-absTBS treatment sequence arm

In the sham-absTBS arm, the blinded sham treatment shall be administered at Week 1. The blinded active absTBS treatment shall be given at Week 3.

Interventions

active accelerated bilateral sequential theta burst stimulation and sham treatment

We shall use the Magpro device (Magventure) employing the specialized Active/Sham B70 coil.

absTBS shall be administered consisting of 6 sessions daily (with a 50-minute interval between treatment sessions) on Mondays to Fridays or for a maximum of 5 working days of daily treatment. The target stimulation intensity will be set at 90 to 120% of the subject's resting motor threshold (RMT). Each session shall be composed of administration of continuous theta burst stimulation (triplet burst pulses at 50 Hz, repeated at 5 Hz, for a total of 600 pulses per session over 40 seconds administered on the right dorsolateral prefrontal cortex) and then intermittent theta burst stimulation (triplet burst pulses at 50 Hz bursts, repeated at 5 Hz, 2 s on and 8 s off, for a total of 600 pulses per session over about 3 min, administered on the left dorsolateral prefrontal cortex).

The sham treatment will be conducted for the same number of sessions and duration as the absTBS treatment sessions.

Primary outcome measure

  • Change in Dual-task Cost [ Time Frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 ]
  • Change in Hamilton Depression Rating Scale 17 (HAMD-17) score [ Time Frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10 ]
  • Adverse events (AE) [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 8, and Week 10 ]

Central Contacts and Locations

Central contacts

Locations

Ontario Shores Centre for Mental Health Sciences

Recruiting

Toronto, Ontario, Canada, L1N 5S9

Contacts

More Information

Sponsor

Ontario Shores Centre for Mental Health Sciences

Last update posted

Mar 21, 2024

Last verified

Mar, 2024

Keywords

  • Treatment-resistant depression
  • Accelerated bilateral sequential theta burst stimulation
  • Repetitive transcranial magnetic stimulation
  • Motoric-cognitive risk syndrome
  • Randomized controlled trial
  • Brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Shores Centre for Mental Health Sciences on 2024-03-21.