Transcranial Magnetic StimulationNCT04486222
Accelerated Bilateral rTMS on Geriatric Depression
A study testing Repeated Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Depressive Disorder, Major, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Depressive Disorder, Major
- What is being tested?
- Repeated Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2020to 21 Dec 2022
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 60-85 years
- literate and received basic education for at least 2 years
- diagnosis of major depressive disorder, without psychotic features, according to DSM-5
- have a score of 20 or greater on the 17-item Hamilton Depression Rating Scale
- failed to achieve clinical response by at least 1 antidepressant trial of sufficient dosage for at least 4 weeks
- psychoactive agents were in stable doses before randomization
Who cannot join
- active suicide plans or attempts; or suicide attempts in the last 12 months
- diagnosis of schizophrenia or bipolar disorder according to DSM-5
- have DSM-5-confirmed substance use disorder (excluding tobacco) in the last 3 months
- have delirium, major neurocognitive disorder or MMSE < 24
- current use of bupropion >300 mg/day, tricyclic antidepressant, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline or anti-epileptic agents excluding benzodiazepines
- history of severe head trauma, epilepsy, multiple sclerosis, stroke, brain tumors, intracranial aneurysm, active intracranial infection, increased intracranial pressure, metallic implants in the brain, major brain surgery or major neurological diseases
- with a cardiac pacemaker or defibrillator
- received rTMS treatment before
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
Douliu
About this study
Official title: Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial
This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.
Read the detailed description
Repeated transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation treatment, showing good therapeutic effect to medicine treatment-refractory patients. Recent studies suggested bilateral DLPFC might be effective to geriatric depression. Accelerated treatment course was reported to have similar therapeutic effect and safety profile with traditional course. The investigators hypothesize accelerated bilateral rTMS is effective to geriatric depression and comorbid anxiety.
Cognitive impairment and decreased parasympathetic tone are common in patients with major depression. The investigators hypothesize cognitive function and physiological indicators improve after accelerated bilateral rTMS.
In this single-center, prospective double-blind, randomized, active-controlled trial, the investigators aim to recruit 100 patients older than 60 years, without neurocognitive disorders, and refractory to one or more antidepressants. The experimental group would receive an rTMS course with high-frequency stimulation at left DLPFC followed by low-frequency inhibition at right DLPFC, two sessions daily, five days a week, and two weeks in total. The standard treatment group would receive an rTMS course with high-frequency stimulation at left DLPFC as standard treatment parameters. Mood, cognition and physiological markers would be monitored every week. The primary outcome is response and remission rate of major depression measured by Hamilton Rating Scale for Depression.
- Being tested
- Repeated Transcranial Magnetic Stimulation
- Keywords
- repeated transcranial magnetic stimulation, geriatric depression, anxiety, cognitive impairment, heart rate variability
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Transcranial Magnetic StimulationDevice
Magstim® Super Rapid² Transcranial Magnetic Stimulation System
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by low-frequency (1Hz) inhibition at right DLPFC (120% motor threshold, 10 trains, 1200 pulses), two sessions daily with a 1.5-hour inter-session interval (L't active-R't active-1.5 hr-L't active-R't active), five days a week, and two weeks in total. Receives: Device: Repeated Transcranial Magnetic Stimulation |
| Standard Treatment Group | Active comparator | The standard treatment group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by sham inhibition at right DLPFC (1Hz, 10 trains, 1200 pulses); after a 1.5-hour inter-session interval, a sham session would be administered at left and right DLPFC (L't active-R't sham-1.5 hr-L't sham-R't sham. The course would be applied five days a week, and two weeks in total. Receives: Device: Repeated Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17)
HAM-D 17 is a scale rating the severity of depression, covering emotional, cognitive and somatic symptoms of depression. Higher scores indicate higher severity. Response to treatment is defined as ≥ 50% decrease in HAM-D 17; remission is defined as ≤ 7 points in HAM-D 17.
Measured: day 1, day 5, day 12, day 19
Secondary outcomes (6)
Degree of Change in Hamilton Anxiety Rating Scale (HAM-A)
HAM-A is a scale rating the severity of anxiety, covering emotional, cognitive and somatic symptoms of anxiety. Higher scores indicate higher severity.
Measured: day 1, day 5, day 12, day 19
Degree of Change in Mini-Mental State Examination (MMSE)
MMSE is a wildly-used tool to evaluate several cognitive function domains.
Measured: day 1, day 5, day 12, day 19
Degree of Change in Stroop Test
Task 1 (word phase) requests a subject to say a color name string (red, green, blue) printed in black; Task 2 (color phase) requests a subject to say the printed colors (red, green, blue) of letter "x" string; Task 3 (interference phase) requests a subject to say the printed colors of a string of color names (red, green, blue).
Measured: day 1, day 5, day 12, day 19
Degree of Change in Trail Making Test
Task 1 requests a subject to connect a sequence of 25 consecutive numbers regardless of their colors; Task 2 requires a subject to connect 25 consecutive numbers in alternative colors.
Measured: day 1, day 5, day 12, day 19
Degree of Change in Verbal Fluency Test
This test requests a subject to speak as many names of vegetables, fishes or fruit as possible in 45 seconds.
Measured: day 1, day 5, day 12, day 19
Degree of Change in Physiological Parameters
ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.
Measured: day 1, day 5, day 12, day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start23 Nov 2020
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Why it stopped: difficulty in recruiting suitable candidate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486222
- Sponsor's protocol ID
- 201910101RIND
- Status last verified
- May 2021
- First submitted
- 15 Jul 2020
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04486222
- Acronym / sponsor ID
- 201910101RIND
- Keywords
- repeated transcranial magnetic stimulation, geriatric depression, anxiety, cognitive impairment, heart rate variability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting suitable candidate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 24 Jul 2020 (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.
This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.
Detailed description
Repeated transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation treatment, showing good therapeutic effect to medicine treatment-refractory patients. Recent studies suggested bilateral DLPFC might be effective to geriatric depression. Accelerated treatment course was reported to have similar therapeutic effect and safety profile with traditional course. The investigators hypothesize accelerated bilateral rTMS is effective to geriatric depression and comorbid anxiety.
Cognitive impairment and decreased parasympathetic tone are common in patients with major depression. The investigators hypothesize cognitive function and physiological indicators improve after accelerated bilateral rTMS.
In this single-center, prospective double-blind, randomized, active-controlled trial, the investigators aim to recruit 100 patients older than 60 years, without neurocognitive disorders, and refractory to one or more antidepressants. The experimental group would receive an rTMS course with high-frequency stimulation at left DLPFC followed by low-frequency inhibition at right DLPFC, two sessions daily, five days a week, and two weeks in total. The standard treatment group would receive an rTMS course with high-frequency stimulation at left DLPFC as standard treatment parameters. Mood, cognition and physiological markers would be monitored every week. The primary outcome is response and remission rate of major depression measured by Hamilton Rating Scale for Depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Repeated Transcranial Magnetic StimulationThe experimental group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by low-frequency (1Hz) inhibition at right DLPFC (120% motor threshold, 10 trains, 1200 pulses), two sessions daily with a 1.5-hour inter-session interval (L't active-R't active-1.5 hr-L't active-R't active), five days a week, and two weeks in total. |
| Standard Treatment Group | Active comparator | Device: Repeated Transcranial Magnetic StimulationThe standard treatment group would receive an rTMS course with high-frequency stimulation (10Hz) at left DLPFC (120% motor threshold, 40 trains, 1600 pulses) followed by sham inhibition at right DLPFC (1Hz, 10 trains, 1200 pulses); after a 1.5-hour inter-session interval, a sham session would be administered at left and right DLPFC (L't active-R't sham-1.5 hr-L't sham-R't sham. The course would be applied five days a week, and two weeks in total. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 60-85 years
- literate and received basic education for at least 2 years
- diagnosis of major depressive disorder, without psychotic features, according to DSM-5
- have a score of 20 or greater on the 17-item Hamilton Depression Rating Scale
- failed to achieve clinical response by at least 1 antidepressant trial of sufficient dosage for at least 4 weeks
Key exclusion criteria (8 listed)
- active suicide plans or attempts; or suicide attempts in the last 12 months
- diagnosis of schizophrenia or bipolar disorder according to DSM-5
- have DSM-5-confirmed substance use disorder (excluding tobacco) in the last 3 months
- have delirium, major neurocognitive disorder or MMSE < 24
- current use of bupropion >300 mg/day, tricyclic antidepressant, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline or anti-epileptic agents excluding benzodiazepines
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 |
|---|---|---|
| Repeated Transcranial Magnetic StimulationMagstim® Super Rapid² Transcranial Magnetic Stimulation System | Device | Experimental Group, Standard Treatment Group |
Primary outcome
Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17)
Time frame: day 1, day 5, day 12, day 19
HAM-D 17 is a scale rating the severity of depression, covering emotional, cognitive and somatic symptoms of depression. Higher scores indicate higher severity. Response to treatment is defined as ≥ 50% decrease in HAM-D 17; remission is defined as ≤ 7 points in HAM-D 17.
6 secondary outcomes
Degree of Change in Hamilton Anxiety Rating Scale (HAM-A)
Time frame: day 1, day 5, day 12, day 19
Degree of Change in Mini-Mental State Examination (MMSE)
Time frame: day 1, day 5, day 12, day 19
Degree of Change in Stroop Test
Time frame: day 1, day 5, day 12, day 19
Degree of Change in Trail Making Test
Time frame: day 1, day 5, day 12, day 19
Degree of Change in Verbal Fluency Test
Time frame: day 1, day 5, day 12, day 19
Degree of Change in Physiological Parameters
Time frame: day 1, day 5, day 12, day 19
Results and safety
The study was stopped early (reason given: difficulty in recruiting suitable candidate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Depressive Disorder, Major, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Jan 2023. 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 Taiwan. 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?
The study was stopped early (reason given: difficulty in recruiting suitable candidate). Results are not available in the source record.
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?
Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17) (time frame: day 1, day 5, day 12, day 19). 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 4 Jan 2023.