Depressive Disorder, Treatment-ResistantCogniTReaDNCT06323486
Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression
A study of Depressive Disorder, Treatment-Resistant, run by Ontario Shores Centre for Mental Health Sciences at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years or older;
- Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of a non-psychotic major depressive disorder;
- Currently in a major depressive episode with a score on HAMD-17 of 17 or more;
- 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);
- 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;
- Passing the TMS safety screen; and
- Those who have the capacity to provide consent and who voluntary consent to participate in the study.
Who cannot join
- Those with MINI-confirmed active substance use disorder within the last 3 months;
- Those with lifetime MINI-confirmed diagnosis of bipolar I disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder;
- Those with major unstable medical comorbidities (i.e., rapidly deteriorating medical/neurological conditions that poses a significant risk to a person's life);
- Those with a diagnosis of dementia confirmed using the Global Clinical Dementia Rating (CDR) with a score greater than or equal to 1.
- 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;
- Those with cardiac pacemaker or implanted mediation pump;
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- 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;
- 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;
- Those who are unable to express and understand using the English language; and
- Individuals who are pregnant or who are likely pregnant.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ontario Shores Centre for Mental Health Sciences
Toronto, Ontario, L1N 5S9
Amer M. Burhan, MBChB, MSc, 905.430.4055 ext. 4019, burhana@ontarioshores.ca
Adrian I. Espiritu, MD, 905.430.4055 ext. 6271, espiritua@ontarioshores.ca
About this study
Official title: Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial
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.
Read the detailed description
The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- active accelerated bilateral sequential theta burst stimulation and sham treatment
- Keywords
- Treatment-resistant depression, Accelerated bilateral sequential theta burst stimulation, Repetitive transcranial magnetic stimulation, Motoric-cognitive risk syndrome, Randomized controlled trial, Brain stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active accelerated bilateral sequential theta burst stimulation and sham treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| absTBS-sham treatment sequence arm | Other | 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. Receives: Device: active accelerated bilateral sequential theta burst stimulation and sham treatment |
| Sham-absTBS treatment sequence arm | Other | 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. Receives: Device: active accelerated bilateral sequential theta burst stimulation and sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dual-task Cost
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Hamilton Depression Rating Scale 17 (HAMD-17) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Adverse events (AE)
An AE is defined as any untoward medical occurrence associated with any of the study interventions (active absTBS or sham) whether or not considered related to the study intervention.
A serious AE to any serious and unforeseen occurrence related or possibly related to the participation in the study that can lead to hospitalization, disability, or death.
Measured: Week 1, Week 2, Week 3, Week 6, Week 8, and Week 10
Secondary outcomes (19)
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making A (TMT-A) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making B (TMT-B) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Symbol Substitution Test (DSST) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Forward (DSF) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Backward (DSB) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Category Verbal Fluency (CVF) score
Measured: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Montreal Cognitive Assessment (MoCA) score
Measured: Week 0 (baseline), Week 2
Change in Colour Word Interference Test (CWIT) score
Measured: Week 0 (baseline), Week 2
Change in Patient Health Questionnaire-9 (PHQ-9) score
Measured: Week 0 (baseline), Week 2
Change in Geriatric Depression Scale 30 (GDS-30) score
Measured: Week 0 (baseline), Week 2
Change in Generalized Anxiety Disorder 7 (GAD-7) score
Measured: Week 0 (baseline), Week 2
Change in Short Form 36 (SF-36) score
Measured: Week 0 (baseline), Week 2
Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score
Measured: Week 0 (baseline), Week 2
Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score
Measured: Week 0 (baseline), Week 2
Change in Clinical Global Impression (CGI) score
Measured: Week 0 (baseline), Week 2
Change in Short Physical Performance Battery (SPPB) score
Measured: Week 0 (baseline), Week 2
Change in Timed Up & Go (TUG) score
Measured: Week 0 (baseline), Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Shores Centre for Mental Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Amer M. Burhan, MBChB, MSc, Principal investigator, Ontario Shores Centre for Mental Health Sciences and University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323486
- Sponsor's protocol ID
- 23-015-B
- Acronym
- CogniTReaD
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data can be made available by request from qualified researchers/investigators.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT06323486
- Acronym / sponsor ID
- CogniTReaD / 23-015-B
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- Treatment-resistant depression, Accelerated bilateral sequential theta burst stimulation, Repetitive transcranial magnetic stimulation, Motoric-cognitive risk syndrome, Randomized controlled trial, Brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ontario Shores Centre for Mental Health SciencesUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity.
| Arm | Type | Receives |
|---|---|---|
| absTBS-sham treatment sequence arm | Other | Device: active accelerated bilateral sequential theta burst stimulation and sham treatmentThose 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. |
| Sham-absTBS treatment sequence arm | Other | Device: active accelerated bilateral sequential theta burst stimulation and sham treatmentIn 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 50 years or older;
- Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of a non-psychotic major depressive disorder;
- Currently in a major depressive episode with a score on HAMD-17 of 17 or more;
- 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);
- 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;
Key exclusion criteria (10 listed)
- Those with MINI-confirmed active substance use disorder within the last 3 months;
- Those with lifetime MINI-confirmed diagnosis of bipolar I disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder;
- Those with major unstable medical comorbidities (i.e., rapidly deteriorating medical/neurological conditions that poses a significant risk to a person's life);
- Those with a diagnosis of dementia confirmed using the Global Clinical Dementia Rating (CDR) with a score greater than or equal to 1.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active accelerated bilateral sequential theta burst stimulation and sham treatmentWe 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. | Device | Sham-absTBS treatment sequence arm, absTBS-sham treatment sequence arm |
Primary outcome
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
An AE is defined as any untoward medical occurrence associated with any of the study interventions (active absTBS or sham) whether or not considered related to the study intervention. A serious AE to any serious and unforeseen occurrence related or possibly related to the participation in the study that can lead to hospitalization, disability, or death.
19 secondary outcomes
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making A (TMT-A) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Trail Making B (TMT-B) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Symbol Substitution Test (DSST) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Forward (DSF) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Digit Span Backward (DSB) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Category Verbal Fluency (CVF) score
Time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Week 0 (baseline), Week 2
Change in Colour Word Interference Test (CWIT) score
Time frame: Week 0 (baseline), Week 2
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Week 0 (baseline), Week 2
Change in Geriatric Depression Scale 30 (GDS-30) score
Time frame: Week 0 (baseline), Week 2
Change in Generalized Anxiety Disorder 7 (GAD-7) score
Time frame: Week 0 (baseline), Week 2
Change in Short Form 36 (SF-36) score
Time frame: Week 0 (baseline), Week 2
Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score
Time frame: Week 0 (baseline), Week 2
Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score
Time frame: Week 0 (baseline), Week 2
Change in Clinical Global Impression (CGI) score
Time frame: Week 0 (baseline), Week 2
Change in Short Physical Performance Battery (SPPB) score
Time frame: Week 0 (baseline), Week 2
Change in Timed Up & Go (TUG) score
Time frame: Week 0 (baseline), Week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data can be made available by request from qualified researchers/investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amer M. Burhan, MBChB, MSc principal investigator
Ontario Shores Centre for Mental Health Sciences and University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depressive Disorder, Treatment-Resistant, run by Ontario Shores Centre for Mental Health Sciences at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amer M. Burhan, MBChB, MSc (905.430.4055 ext. 4019, burhana@ontarioshores.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dual-task Cost (time frame: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.