Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

January 1, 2027

Study Completion Date

June 15, 2027

Conditions
Mild Cognitive Impairment
Interventions
DEVICE

1. rTMS + CS

"In the first phase each participant will receive 15 sessions of rTMS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of rTMS and 1 session of CS per week for 12 weeks. Each session will consist of 10 trains of 10 stimuli, at a 5-Hz frequency and a stimulation intensity of 120% of the resting motor threshold.~rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70.~Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The rTMS condition will be double-blinded through the use of a USB stick.~Cognitive stimulation will be a Mexican adaptation of the Memory Training and Cognitive Stimulation for Mild Cognitive Impairment from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.~In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS."

DEVICE

2. rTMS Sham + CS

"In the first phase each participant will receive 15 sessions of rTMS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham rTMS and 1 session of CS per week for 12 weeks.~In total, each participant will receive 27 sessions of Sham rTMS and 21 sessions of CS.~rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70.~Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The sham condition will be double-blinded through the use of a USB stick.~Cognitive stimulation will be a Mexican adaptation of the Memory Training and Cognitive Stimulation for Mild Cognitive Impairment from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.~In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS."

DEVICE

3. tDCS + CS

"In the first phase each participant will receive 15 sessions of tDCS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of tDCS and 1 session of CS per week for 12 weeks. Each session will consist of the delivery of a weak direct current of 2mA for 30 minutes.~tDCS will be administered by the Sooma tDCS stimulator. The tDCS condition will be double-blinded, and a third operator will program the stimulator.~Cognitive stimulation will be a Mexican adaptation of the Memory Training and Cognitive Stimulation for Mild Cognitive Impairment from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.~In total, each participant will receive 27 sessions of tCDS and 21 sessions of CS."

DEVICE

4. tDCS Sham + CS

"In the first phase each participant will receive 15 sessions of tDCS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham tDCS and 1 session of CS per week for 12 weeks.~tDCS will be administered by the Sooma tDCS stimulator. The sham condition will be double-blinded, and a third operator will program the stimulator.~Cognitive stimulation will be a Mexican adaptation of the Memory Training and Cognitive Stimulation for Mild Cognitive Impairment from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.~In total, each participant will receive 27 sessions of Sham tDCS and 21 sessions of CS."

Trial Locations (1)

14370

RECRUITING

Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Mexico City

All Listed Sponsors
lead

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

OTHER