rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia

Behavioral and Psychiatric Symptoms of Dementia Clinical Trial

— rTMS-PSYGER  

Official title:

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05262868
• Other study ID #: 2021-D0067
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 S (*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

Related Conditions & MeSH terms

• Affective Symptoms
• Behavioral and Psychiatric Symptoms of Dementia
• Dementia

Intervention

Device:
• rTMS
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.

Locations

Country	Name	City	State
Switzerland	Supaa - Chuv	Prilly	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cornell Scale for Depression in Dementia (CSDD)	Mood assessment tool	from baseline to day 20
Secondary	Montreal Cognitive Assessment (MOCA)	Cognitive assessment tool	from baseline to day 20
Secondary	NPI-Q	Behavioural assessment tool for demented patients	from baseline to day 20
Secondary	The ratio of patients who completed the study and drop-outs due to non-compliance	Compliance assessment tool	During all the study period
Secondary	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.	from baseline to day 20