Old AgeNCT03978182
Accelerated Deep TMS in the Elderly Depressed: A Brain Imaging Approach
A study testing accelerated deep rTMS in people with Old Age and Depression, run by Universitair Ziekenhuis Brussel.
Trial summary
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age, Depression
- What is being tested?
- accelerated deep rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- In and outpatients (age 65 year or older) meeting Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more, who failed to respond to at least one adequate course with an antidepressant medication trial, including the current one. Stable current antidepressant treatment (>6 weeks) will be continued during the stimulation.
- Able to read, understand and sign the Informed Consent Form.
Who cannot join
- Psychosis (exception: depression with psychotic features)
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, abuse substance, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings and the presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with some neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm.
- Patients with cognitive disturbances or dementia will not be included (Mini Mental State) < 24.
- Suicide attempt within 6 months before the start of the study or present risk of Suicide with the Columbia-Suicide Severity Rating Scale (C-SSRS).
- ECT exposure (current major depressive episode)
About this study
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) may be a solution. Given recent positive results with accelerated rTMS in the elderly depressed, it is of interrest to continue to develop promising non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled cross-over fashion, the investigators will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), and evaluate clinical efficacy and safety. Because new introduced rTMS paradigms should be rigorously neurobiologically examined before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of this application in order to optimize treatment for such populations.
Read the detailed description
An initially double-blind sham-controlled cross-over study in geriatric depressed patients to investigate whether accelerated (a)dTMS is a safe and effective clinical option for this cohort. After the first week evaluations and MRI, there will be an open label phase in which patients who did receive active treatment in the first week will not receive any further rTMS sessions, those patients who had received sham however will get their active treatment in the second week. The independent researcher will use the treatment allocation list to inform the investigators if an active treatment faze is needed in the second week.
- Conditions
- Old Age, Depression
- Being tested
- accelerated deep rTMS
- Keywords
- repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated deep rTMSDevice
A Magstim Rapid2 Plus1 Magnetic Stimulator connected to the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). The coil is situated inside a helmet to achieve effective cooling during stimulation. A sham coil is also included in the same helmet. The sham coil mimics scalp sensations and the acoustic artifact of the active stimulation without inducing neuronal activation.
| Study group | Role | What they receive |
|---|---|---|
| active accelerated deep rTMS | Active comparator | Stimulation: We will use a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil, which includes a sham option. In analogy to our former accelerated rTMS studies (2, 3), all patients will receive 20 dTMS sessions (5 sessions per day; 4 consecutive days) with a stimulation intensity of 120% of the subject's resting MT, as reported by Levkovitz et al.(4). Furthermore, we selected these FDA approved dTMS parameters, so that for one session each dTMS repetition includes 2-sec pulse trains separated by 20-sec inter-train intervals. Patients will receive 55 trains in each treatment session, for a total of 1980 pulses per session. This makes 9900 pulses/day, and in total 39600 pulses per treatment. Receives: Device: accelerated deep rTMS |
| sham | Sham comparator | Built-in sham in the H1 Helmet (same device as active treatment) Receives: Device: accelerated deep rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by questionning the patient on each stimulation day
Measured: During 1 week (and 2 weeks for patients who received sham in the first week)
clinical efficacy measured by change in the 17 item Hamilton Depression rating Scale score.
for a total score between 0 and 48, the higher the total score the more severe the depression. Used measures are : for response (reduction from baseline of ≥ 50% in the total score) and remission (total HAMD-17 score ≤ 7)
Measured: from screening until last visit (week 4)
clinical efficacy measured by change in the Beck-Inventory of Depression-II score
for a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission, and BDI-II score decrease of 50% from baseline is the criterion for treatment response.
Measured: from screening until last visit (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: replaced by other study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies 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
- Crossover
- Model description
- geriatric depressed patients after randomization at time T1 (on a Monday for MRI) will be divided into two groups to receive 20 sessions of real or sham adTMS treatment respectively. A given patient who first received active treatment will not receive sham, because of the carry-over effects; a patient who first received sham treatment now receives active adTMS in an open phase. This treatment will be spread over the four succeeding afternoons (5 daily sessions). In the second week, strictly the same treatment schedule will be followed but with the reverse order. A second brain imaging assessment will be performed exactly 1 week after the first week (time T2) and a third time scan exactly after 2 weeks (time T3).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Baeken, MD Phd, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978182
- Sponsor's protocol ID
- 2019-190
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Deep TMS in the Elderly Depressed: A Brain Imaging Approach
- ClinicalTrials.gov ID
- NCT03978182
- Acronym / sponsor ID
- 2019-190
- Conditions
- Old Age, Depression
- Keywords
- repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: replaced by other study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Jun 2019 (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.
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) may be a solution. Given recent positive results with accelerated rTMS in the elderly depressed, it is of interrest to continue to develop promising non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled cross-over fashion, the investigators will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), and evaluate clinical efficacy and safety. Because new introduced rTMS paradigms should be rigorously neurobiologically examined before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of this application in order to optimize treatment for such populations.
Detailed description
An initially double-blind sham-controlled cross-over study in geriatric depressed patients to investigate whether accelerated (a)dTMS is a safe and effective clinical option for this cohort. After the first week evaluations and MRI, there will be an open label phase in which patients who did receive active treatment in the first week will not receive any further rTMS sessions, those patients who had received sham however will get their active treatment in the second week. The independent researcher will use the treatment allocation list to inform the investigators if an active treatment faze is needed in the second week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- geriatric depressed patients after randomization at time T1 (on a Monday for MRI) will be divided into two groups to receive 20 sessions of real or sham adTMS treatment respectively. A given patient who first received active treatment will not receive sham, because of the carry-over effects; a patient who first received sham treatment now receives active adTMS in an open phase. This treatment will be spread over the four succeeding afternoons (5 daily sessions). In the second week, strictly the same treatment schedule will be followed but with the reverse order. A second brain imaging assessment will be performed exactly 1 week after the first week (time T2) and a third time scan exactly after 2 weeks (time T3).
| Arm | Type | Receives |
|---|---|---|
| active accelerated deep rTMS | Active comparator | Device: accelerated deep rTMSStimulation: We will use a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil, which includes a sham option. In analogy to our former accelerated rTMS studies (2, 3), all patients will receive 20 dTMS sessions (5 sessions per day; 4 consecutive days) with a stimulation intensity of 120% of the subject's resting MT, as reported by Levkovitz et al.(4). Furthermore, we selected these FDA approved dTMS parameters, so that for one session each dTMS repetition includes 2-sec pulse trains separated by 20-sec inter-train intervals. Patients will receive 55 trains in each treatment session, for a total of 1980 pulses per session. This makes 9900 pulses/day, and in total 39600 pulses per treatment. |
| sham | Sham comparator | Device: accelerated deep rTMSBuilt-in sham in the H1 Helmet (same device as active treatment) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- In and outpatients (age 65 year or older) meeting Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more, who failed to respond to at least one adequate course with an antidepressant medication trial, including the current one. Stable current antidepressant treatment (>6 weeks) will be continued during the stimulation.
- Able to read, understand and sign the Informed Consent Form.
Key exclusion criteria (5 listed)
- Psychosis (exception: depression with psychotic features)
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, abuse substance, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings and the presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with some neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm.
- Patients with cognitive disturbances or dementia will not be included (Mini Mental State) < 24.
- Suicide attempt within 6 months before the start of the study or present risk of Suicide with the Columbia-Suicide Severity Rating Scale (C-SSRS).
- ECT exposure (current major depressive episode)
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 |
|---|---|---|
| accelerated deep rTMSA Magstim Rapid2 Plus1 Magnetic Stimulator connected to the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). The coil is situated inside a helmet to achieve effective cooling during stimulation. A sham coil is also included in the same helmet. The sham coil mimics scalp sensations and the acoustic artifact of the active stimulation without inducing neuronal activation. | Device | active accelerated deep rTMS, sham |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: During 1 week (and 2 weeks for patients who received sham in the first week)
Number of participants with treatment-related adverse events as assessed by questionning the patient on each stimulation day
clinical efficacy measured by change in the 17 item Hamilton Depression rating Scale score.
Time frame: from screening until last visit (week 4)
for a total score between 0 and 48, the higher the total score the more severe the depression. Used measures are : for response (reduction from baseline of ≥ 50% in the total score) and remission (total HAMD-17 score ≤ 7)
clinical efficacy measured by change in the Beck-Inventory of Depression-II score
Time frame: from screening until last visit (week 4)
for a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission, and BDI-II score decrease of 50% from baseline is the criterion for treatment response.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Chris Baeken, MD Phd study director
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing accelerated deep rTMS in people with Old Age and Depression, run by Universitair Ziekenhuis Brussel.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: During 1 week (and 2 weeks for patients who received sham in the first week)). 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 2 Mar 2021.