Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer Disease (AD-EMTr)
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|ClinicalTrials.gov Identifier: NCT03270137|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Transcranial Magnetic Stimulation||Device: repetitive transcranial magnetic stimulation- IDLPFC Device: repetitive transcranial magnetic stimulation - Six regions||Not Applicable|
Alzheimer disease (AD) is a neurodegenerative disorder characterized by progressive cognitive decline that affects behavior and daily functionality. Its etiology is unknown and treatment efficacy is partial. Repetitive transcranial magnetic stimulation has been suggested as a potential treatment as of several trials has revealed improvements in language, episodic memory, psychological and behavioral symptoms in dementia as well as functionality using different experimental designs, stimulation parameters and cortical targets comparisons. However, it remains to determine the most effective modality, comparing outcomes with cortical targets poorly studied and how much the effects last. The main objective of this study is to determine which of two stimulation modalities provides a better cognitive and behavioral effect also on functionality in patients with potential diagnosis of AD, administered over lDLPFC (Condition A) and a six areas condition (Condition B) in which are alternated two sub-conditions (Day 1: Broca and Wernicke areas and lDLPFC, and Day 2: bilateral parietal association cortex and rDLPFC) along 15 sessions and 1500 pulses per session.
For this purpose, will be randomized 22 patients with potential diagnosis of AD (according to DSM-5) to both stimulation conditions (11 patients to each condition). The rTMS will be administered at 5 Hz and 1500 pulses per session (30 trains and 10 seconds inter-train interval) along 15 sessions with a post-treatment evaluation at 4 weeks comparing: time response, post-treatment effects and 4 weeks effects.
To evaluate clinical response among stimulation conditions will be used Alzheimer´s Disease Assessment Scale COGNITIVE (ADAS-cog), Cumming's Neuropsychiatric Inventory (NPI), Yesavage Geriatric Depression Scale (GDS), Interview for Deterioration-in-daily Living Activities in Dementia (IDDD) and Clinical Global Impression (CGI). The modified version of Mini Mental State (MMSE-FOLSTEIN) will be applied in the same time points of other evaluations also at the session 5 and 10. Other interest variables are: age, sex, civil status, education, occupation, time and type of pharmacological treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking Description:||Single Blind (Investigator)|
|Official Title:||Cognitive, Behavioral and Functional Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Potential Alzheimer Disease: Two Treatment Modalities Comparison|
|Actual Study Start Date :||March 10, 2016|
|Actual Primary Completion Date :||February 28, 2017|
|Estimated Study Completion Date :||August 31, 2017|
Active Comparator: Condition A: rTMS on L-DLPFC
Repetitive transcranial magnetic stimulation- IDLPFC. The intervention will be rTMS delivered on left dorsolateral prefrontal cortex (L-DLPFC).
Every patient will receive 15 rTMS sessions (in weekdays) along three weeks at 5 Hz of frequency and at its 100% of motor threshold. Each session will consist of 30 trains separated by 10 seconds inter-train interval and 1500 total pulses per session.
Equipment to rTMS includes a Magpro R30 stimulator (Magventure, Denmark) with an 8-shape coil model MCF-B70.
Device: repetitive transcranial magnetic stimulation- IDLPFC
Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC). Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
Active Comparator: Condition B: rTMS on six regions
Repetitive transcranial magnetic stimulation - Six regions. Two sub-conditions will alternate each session, starting with day 1: rTMS on Broca and Wernicke area and lDLPFC and then day 2: rTMS on left and right parietal association cortex (lPAC; rPAC) and right dorsolateral prefrontal cortex (rDLPFC).
Patients will receive 15 intervention sessions (in weekdays) along three weeks at 5 Hz frequency and 100% of motor threshold. Each area will receive 10 trains (500 pulses) separated by 10 seconds of inter-train interval that correspond to 1500 total pulses per session.
Equipment to rTMS includes a Magpro stimulator (Dantec, Denmark) with an 8-shape coil model MC-B70.
Device: repetitive transcranial magnetic stimulation - Six regions
Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered on six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
- Changes on cognitive functioning (ADAS-cog) [ Time Frame: Baseline, Post rTMS treatment: at week 3, and at week 4. ]ADAS-cog is cognitive testing instrument to measure severity. It explores 11 domains including memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD.
- Changes on cognitive effects (Mini Mental State) [ Time Frame: Baseline, every week for 3 weeks during rTMS treatment and at the 4th week after treatment. ]This instrument gives scores to orientation in time and space, registration information (three words) and recovering, attention, calculation, language (denomination, repetition, understanding of complex orders, reading and writing) and finally visuoconstruction (two overlapping diamonds).
- Changes on behavioral symptoms (NPI) [ Time Frame: Baseline, Post rTMS treatment: at week 3, and at week 4. ]This is a diagnostic instrument to determine the presence of behavioral symptoms. It measures frequency and severity of symptoms in the last month and the overload for the caregiver. This test divides behavioral symptoms in: delirium, hallucinations, agitation or aggressivity, anxiety, euphoria, apathy, irritability/lability, disinhibition, aberrant motor behavior, sleep and appetite/feeding.
- Changes on depression symptoms (GDS-Yesavage) [ Time Frame: Baseline, Post rTMS treatment: at week 3, and at week 4. ]Repeated application allows to evaluate changes in the geriatric depression evolution.
- Changes on effects on functionality (IDDD) [ Time Frame: Baseline, Post rTMS treatment: at week 3, and at week 4. ]This is an instrument designed to evaluate functionality in dementia. It evaluates self-care and complex activities.
- Changes on Clinical Global Impression (CGI) [ Time Frame: Baseline, Post rTMS treatment: at week 3, and at week 4. ]Standardized and descriptive scale, it gives qualitative information to identify changes in the illness through measuring severity of clinical picture and improvements triggered by treatments (change in the time) as well as treatment efficacy.