Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer Disease

NCT03270137 | Unknown DMC

• 1 other identifier: SIC-16-001
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized clinical trial, comparative and single blind aims to determine effects on cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive transcranial magnetic stimulation (rTMS) 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.

Conditions

Alzheimer Disease; Transcranial Magnetic Stimulation

Keywords

Alzheimer Disease; rTMS; Cognition; Behavioral Symptoms; Functionality

Outcome Measures

Primary Outcomes (1)

• Changes on cognitive functioning (ADAS-cog)

  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.

  Baseline, Post rTMS treatment: at week 3, and at week 4.

Secondary Outcomes (5)

• Changes on cognitive effects (Mini Mental State)

  Baseline, every week for 3 weeks during rTMS treatment and at the 4th week after treatment.

• Changes on behavioral symptoms (NPI)

  Baseline, Post rTMS treatment: at week 3, and at week 4.

• Changes on depression symptoms (GDS-Yesavage)

  Baseline, Post rTMS treatment: at week 3, and at week 4.

• Changes on effects on functionality (IDDD)

  Baseline, Post rTMS treatment: at week 3, and at week 4.

• Changes on Clinical Global Impression (CGI)

  Baseline, Post rTMS treatment: at week 3, and at week 4.

Study Arms (2)

Condition A: rTMS on L-DLPFC

ACTIVE COMPARATOR

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

Condition B: rTMS on six regions

ACTIVE COMPARATOR

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

Interventions

repetitive transcranial magnetic stimulation- IDLPFC DEVICE

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.

Condition A: rTMS on L-DLPFC

repetitive transcranial magnetic stimulation - Six regions DEVICE

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.

Condition B: rTMS on six regions

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with file number at National Institute of Psychiatry "Ramón de la Fuente Muñiz".
• Scholarship of at least 5 years or above.
• Dementia diagnosis established by clinical examination made by their responsible physician, according the Diagnose Criteria for Alzheimer Disease for possible, mild or moderate according to DSM-5. Severity will be stratified with Mini-Mental State (MMSE-FOLSTEIN): as a) mild: 21-26 and b) moderated 15-20 points; in addition, with Reisberg Global Deterioration, the states from 2 to 4 that correspond a cognitive deficit mild and moderated.
• In the case of concomitant treatment with memantine or acetylcholinesterase inhibitors, the patient should have taken it for at least 6 months prior to study.
• In the case of other pharmacological treatments for psychiatric conditions, for example, antidepressants, anxiolytic or antipsychotics, the patient should have taken stable doses for at least 2 months.
• Patients with another no-psychiatric comorbidity should be stable (according to diagnostic criteria and supported by laboratory studies or metric assessments).
• Every patient should have a caregiver (for example, spouse, a relative or a professional caregiver) along the study who could stay with the patient at least 10 hours/week.
• Signing of informed consent by patient and caregiver.
• Patients and caregivers who can attend in weekdays, along three weeks assessments and treatment sessions at National Institute of Psychiatry "Ramón de la Fuente Muñiz".

You may not qualify if:

• Patients with severe agitation symptoms or difficulties to cooperate with the study.
• Patients with history of epilepsy.
• Patients with sudden onset of apoplexy, focal neurologic findings as hemiparesis, sensory loss, visual field deficit and lack of coordination in the legs in early stages of disease.
• Convulsion or walking disorder at onset or very early stages of the disease.
• Patients with history of severe psychiatric disorders.
• Patients with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a specialized clinical neurophysiologist).
• Patients with pacemaker or implanted metallic intracranial objects.
• Elimination criteria:
• Decision of patient or caregiver to left the study.
• Modification in doses or pharmacological treatment prior to start the study.
• Patients with new clinical findings and who require complementary pharmacological treatment.
• Presence of adverse events that could affect health and could limit maintain the patient in treatment.
• Exacerbation of cognitive or behavioral symptoms during the study.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead
• National Council of Science and Technology, Mexico: collaborator

MeSH Terms

Conditions

Alzheimer Disease; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single Blind (Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 1, 2017
• Study Start: March 10, 2016
• Primary Completion: February 28, 2017
• Study Completion: August 31, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08