An interventional study of rTMS and Sham rTMS in Alzheimer Disease, Late Onset, Alzheimer Disease and Cognitive Deterioration, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Status unknown at 1 site in Italy. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Treatment
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
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The treatment will consist in the individually tailored stimulation of a DMN node (i.e. left inferior parietal lobe).
Device: rTMS
The treatment will consist in the individually tailored stimulation of a CEN node (i.e. left dorsolateral prefrontal cortex).
Device: rTMS
The treatment will consist in targeting the upper part of the scalp (i.e. CZ) while using a sham rTMS coil.
Device: Sham rTMS
25 min of high frequency (20 Hz) repetitive TMS applied at 100% of resting motor threshold (rMT).
Placebo intervention will consist in the same procedure but using a sham rTMS coil.
Change in ADAS-Cog scale scores
A brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia
Time frame: At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
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)
Time frame: At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
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.
Time frame: At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Change in brain plasticity
A theta burst stimulation (TBS) protocol will be used to probe plasticity changes
Time frame: At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
Change in MRI measures of functional and structural connectivity
Time frame: At baseline (T0), up to 4 weeks (T1), through study completion, an average of 6 months (T2)
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Centro San Giovanni di Dio Fatebenefratelli