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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04263194
Other study ID # GR-2016-02364718
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2019
Est. completion date March 21, 2024

Study information

Verified date March 2023
Source IRCCS Centro San Giovanni di Dio Fatebenefratelli
Contact Debora Brignani
Phone 0303501597
Email dbrignani@fatebenefratelli.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Severe alterations of brain networks connectivity have been described in Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained evidence as an effective tool to modulate brain networks connectivity, leading to a recovery or reorganization of both local and remote brain regions functionally connected to the stimulated area. The investogators propose an innovative tailored network-based rTMS treatment to ameliorate cognitive symptoms in mild AD, through the boosting of connectivity within brain networks affected by AD pathophysiology. The combination of the proposed intervention with an integrated multi-modal imaging approach will allow to evaluate the neural mechanisms underlying the clinical response to the treatment and to define quantitative markers of clinical impact on AD. If successful, the present proposal would immediately impact on patient's quality of life, with important implications for the time and costs of delivery of rehabilitative services.


Description:

Currently, no effective cure is available for Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained increasing attention as a potential treatment for various neurological and psychiatric disorders, but available rTMS studies are flawed by inaccurate anatomical targeting, inadequate sample size, unsatisfactory controls and lacking blindness. To date, the elective target area of rTMS interventions in AD has been the dorsolateral prefrontal cortex (DLPFC), a core area of the Central Executive network (CEN), which plays a key role in regulating executive functions, attention and working memory. While the CEN has recently been described as dysfunctional in AD, AD pathophysiology has been mainly associated with the breakdown of the Default Mode network (DMN) and with structural disconnection of its parietal nodes. The DMN plays a crucial role in episodic memory retrieval and incorporates various brain regions, among which parietal areas are highly connected with the rest of the brain. The present multicenter, double-blind, randomized and placebo-controlled study has the ambition to provide evidence of the efficacy of two tailored network-based rTMS treatments in mild AD, through the enhancement of connectivity of CEN and DMN. Innovative integrated multi-modal imaging investigations will further enrich this proposal allowing to identify quantifiable markers underlying the clinical impact of rTMS on AD.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 21, 2024
Est. primary completion date September 21, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: - Mini-Mental State Examination score >=16, <=24 - Anti-cholinesterase treatment for at least 3 months prior the start date Exclusion Criteria: - Enrollment in other clinical and pharmacological trials - Previous evidence of any other CNS disorder (e.g. epilepsy, infectious diseases, frontotemporal, Parkinson or Pick's disease) - History of major psychiatric disorders - History of alchol or substance abuse - Stress-related skin problems - Current consumption of psychiatric medication - Presence of metal implants or any implanted electronics

Study Design


Intervention

Device:
rTMS
25 min of high frequency (20 Hz) repetitive TMS applied at 100% of resting motor threshold (rMT).
Sham rTMS
Placebo intervention will consist in the same procedure but using a sham rTMS coil.

Locations

Country Name City State
Italy IRCCS Centro San Giovanni di Dio Fatebenefratelli Brescia Lombardia

Sponsors (3)

Lead Sponsor Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli I.R.C.C.S. Fondazione Santa Lucia, Ministero della Salute, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ADAS-Cog scale scores A brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Secondary Change in CANTAB battery scores The scores on two tests of CANTAB battery (www.cambridgecognition.com):
Change in Associative Learning test (PAL)
Change in Spatial Working Memory test (SWM)
At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Secondary Change in brain connectivity TMS-evoked cortical responses (TEPs) will serve as markers of reactivity of the stimulated area as well as markers of the connectivity between targeted cortex and functionally connected areas underlying DMN or CEN. At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Secondary Change in brain plasticity A theta burst stimulation (TBS) protocol will be used to probe plasticity changes At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Secondary Change in MRI measures of functional and structural connectivity At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
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