Back to resultsrTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia (rTMS-PSYGER)
Primary Purpose
Behavioral and Psychiatric Symptoms of Dementia
Status
Active
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Behavioral and Psychiatric Symptoms of Dementia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Supaa - Chuv
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Sham
Arm Description
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
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).
Outcomes
Primary Outcome Measures
Cornell Scale for Depression in Dementia (CSDD)
Mood assessment tool
Secondary Outcome Measures
Montreal Cognitive Assessment (MOCA)
Cognitive assessment tool
NPI-Q
Behavioural assessment tool for demented patients
The ratio of patients who completed the study and drop-outs due to non-compliance
Compliance assessment tool
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.
Full Information
NCT ID
NCT05262868
First Posted
February 21, 2022
Last Updated
February 21, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT05262868
Brief Title
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
Acronym
rTMS-PSYGER
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral and Psychiatric Symptoms of Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cornell Scale for Depression in Dementia (CSDD)
Description
Mood assessment tool
Time Frame
from baseline to day 20
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA)
Description
Cognitive assessment tool
Time Frame
from baseline to day 20
Title
NPI-Q
Description
Behavioural assessment tool for demented patients
Time Frame
from baseline to day 20
Title
The ratio of patients who completed the study and drop-outs due to non-compliance
Description
Compliance assessment tool
Time Frame
During all the study period
Title
Possible changes of structural MRI before as compared to after the treatment
Description
quantitative structural MRI protocol allowing for an optimal segmentation - resolution of grey versus white matter including cortical and sub-cortical brain structures.
Time Frame
from baseline to day 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin von Gunten, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Supaa - Chuv
City
Prilly
State/Province
Vaud
ZIP/Postal Code
1008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
We'll reach out to this number within 24 hrs