Behavioral and Psychiatric Symptoms of DementiaPhase 4rTMS-PSYGERNCT05262868
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
A Phase 4 study testing rTMS in people with Behavioral and Psychiatric Symptoms of Dementia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Behavioral and Psychiatric Symptoms of Dementia
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2022to 31 Jan 2024
- Phase
- Phase 4
- 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
- Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form)
- Consent for MRI
- Age ≥ 65 years
- Clinical dementia Rating Scale (CDR) ≥ 1
- NPI-Q Σ (*Anxiety + * Apathy/Indifference + * Dysphoria/Depression) ≥ 3
- Cornell Scale for Depression in Dementia (CSDD) ≥ 10
Who cannot join
- History of schizophrenia, bipolar disorder, schizoaffective disorder
- History of macroscopic stroke.
- Unstable somatic pathologies
- Insufficient collaboration for the rTMS procedure
- Drug freeness or drug adjustment as clinically required is not an exclusion criterion.
- The proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study.
- Any contraindications to performing an MRI (cf CRF) and rTMS (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks
- Being tested
- rTMS
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
The stimulus intensity will be 80% of the motor threshold and the frequency will be 20 Hz for all patients. The total number of pulses will be 1200 for a single treatment session. We plan a total of 15 sessions distributed over 5 days a week for 3 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Magnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks Receives: Device: rTMS |
| Sham | Placebo comparator | Sham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies). Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornell Scale for Depression in Dementia (CSDD)
Mood assessment tool
Measured: from baseline to day 20
Secondary outcomes (4)
Montreal Cognitive Assessment (MOCA)
Cognitive assessment tool
Measured: from baseline to day 20
NPI-Q
Behavioural assessment tool for demented patients
Measured: from baseline to day 20
The ratio of patients who completed the study and drop-outs due to non-compliance
Compliance assessment tool
Measured: During all the study period
Possible changes of structural MRI before as compared to after the treatment
quantitative structural MRI protocol allowing for an optimal segmentation - resolution of grey versus white matter including cortical and sub-cortical brain structures.
Measured: from baseline to day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral and Psychiatric Symptoms of DementiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Armin von Gunten, Centre Hospitalier Universitaire Vaudois
- Investigators
- Armin von Gunten, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262868
- Sponsor's protocol ID
- 2021-D0067
- Acronym
- rTMS-PSYGER
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Mar 2022
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05262868
- Acronym / sponsor ID
- rTMS-PSYGER / 2021-D0067
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Mar 2022 (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 is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: rTMSMagnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks |
| Sham | Placebo comparator | Device: rTMSSham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form)
- Consent for MRI
- Age ≥ 65 years
- Clinical dementia Rating Scale (CDR) ≥ 1
- NPI-Q Σ (*Anxiety + * Apathy/Indifference + * Dysphoria/Depression) ≥ 3
Key exclusion criteria (7 listed)
- History of schizophrenia, bipolar disorder, schizoaffective disorder
- History of macroscopic stroke.
- Unstable somatic pathologies
- Insufficient collaboration for the rTMS procedure
- Drug freeness or drug adjustment as clinically required is not an exclusion criterion.
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 |
|---|---|---|
| rTMSThe stimulus intensity will be 80% of the motor threshold and the frequency will be 20 Hz for all patients. The total number of pulses will be 1200 for a single treatment session. We plan a total of 15 sessions distributed over 5 days a week for 3 consecutive weeks. | Device | Active, Sham |
Primary outcome
Cornell Scale for Depression in Dementia (CSDD)
Time frame: from baseline to day 20
Mood assessment tool
4 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: from baseline to day 20
NPI-Q
Time frame: from baseline to day 20
The ratio of patients who completed the study and drop-outs due to non-compliance
Time frame: During all the study period
Possible changes of structural MRI before as compared to after the treatment
Time frame: from baseline to day 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- 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.
Armin von Gunten, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rTMS in people with Behavioral and Psychiatric Symptoms of Dementia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 7 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 2 Mar 2022. 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 Switzerland. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Cornell Scale for Depression in Dementia (CSDD) (time frame: from baseline to day 20). 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 2022.