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| Name | Class |
|---|---|
| Neuronix Ltd | INDUSTRY |
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This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.
This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.
TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS with real cognitive training | Active Comparator | High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training. |
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| Sham rTMS with real cognitive training | Sham Comparator | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training. |
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| Sham rTMS with sham cognitive training | Sham Comparator | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent sham cognitive training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score). | Pre treatment; 1 month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Change (CGIC) | The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline. | Pre-treatment, 1 month post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pascual-Leone, M.D., Ph.D. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21246222 | Background | Bentwich J, Dobronevsky E, Aichenbaum S, Shorer R, Peretz R, Khaigrekht M, Marton RG, Rabey JM. Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer's disease: a proof of concept study. J Neural Transm (Vienna). 2011 Mar;118(3):463-71. doi: 10.1007/s00702-010-0578-1. Epub 2011 Jan 19. | |
| 32733232 |
| Label | URL |
|---|---|
| Related Information to the Alzheimer's Trial; sponsors website. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS With Real Cognitive Training | High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| FG001 | Sham rTMS With Real Cognitive Training | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| FG002 | Sham rTMS With Sham Cognitive Training | High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Total number analyzed: 21 (1 enrolled was excluded from analysis) Real/Real: 10 Real/Sham: 5 Sham/Sham: 6
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS With Real Cognitive Training | High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score). | Posted | Mean | Standard Deviation | percentage change | Pre treatment; 1 month post treatment |
|
Adverse events were collected from baseline to 1 month post-treatment
All adverse events were self-reported according to a Side Effects Questionnaire administered at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS With Real Cognitive Training | High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib Fracture | Injury, poisoning and procedural complications | A subject sustained a 5cm contusion and subtle rib fracture resulting from a fall at home. Subject was brought to the hospital for evaluation. Subject was in the follow up phase. This was assessed as unlikely related to to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | Subject experienced twitching in bicep and wrist flexor of the right arm at the beginning of a TMS session that lasted for 5 seconds and resolved. Subject also reported nausea and session was discontinued. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Pascual-Leone, M.D., Ph.D. | Beth Israel Deaconess Medical Center | 617-667-0203 | apleone@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
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| NICE Cognitive Training | Behavioral | 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive sham cognitive training that follows the same procedures as the active group. |
|
|
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | 23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline. | Pre-treatment, 1 month Post-treatment |
| Brem AK, Di Iorio R, Fried PJ, Oliveira-Maia AJ, Marra C, Profice P, Quaranta D, Schilberg L, Atkinson NJ, Seligson EE, Rossini PM, Pascual-Leone A. Corticomotor Plasticity Predicts Clinical Efficacy of Combined Neuromodulation and Cognitive Training in Alzheimer's Disease. Front Aging Neurosci. 2020 Jul 8;12:200. doi: 10.3389/fnagi.2020.00200. eCollection 2020. |
| Related Information regarding the TMS lab at Beth Israel Deaconess Medical Center | View source |
| BG001 | Sham rTMS With Real Cognitive Training | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| BG002 | Sham rTMS With Sham Cognitive Training | High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Sham rTMS With Real Cognitive Training | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. |
| OG002 | Sham rTMS With Sham Cognitive Training | High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group |
|
|
| Secondary | Clinical Global Impression of Change (CGIC) | The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline. | Posted | Mean | Standard Deviation | percent change | Pre-treatment, 1 month post treatment |
|
|
|
| Secondary | Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | 23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline. | Posted | Mean | Standard Deviation | percent change | Pre-treatment, 1 month Post-treatment |
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Sham rTMS With Real Cognitive Training | High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus). A particular cognitive exercise will start 200msec after the termination of each TMS train. Sham participants receive real cognitive training that follows the same procedures as the active group. | 0 | 6 | 5 | 6 |
| EG002 | Sham rTMS With Sham Cognitive Training | High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area). Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day). Sham participants will receive the same study procedures as patients receiving active rTMS. Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group | 1 | 6 | 0 | 6 |
|
|
| Headache | Nervous system disorders | Reported headaches ranged from mild to moderate post-intervention as compared to pre-intervention. Most were assessed as possibly/probably related to the study. |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Reported mild neck pain/stiffness post-intervention. |
|
| Scalp Pain | Musculoskeletal and connective tissue disorders | Reported mild scalp pain post-intervention |
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| Hearing Impairment | Ear and labyrinth disorders | Reported mild hearing impairment post-intervention as compared to pre-intervention. Earplugs were worn throughout every session. No long term hearing impairment reported. |
|
| Impaired Cognition | Nervous system disorders | Reported mild impaired cognition post-intervention compared to pre-intervention. Most reported as tiredness. No long term impairment reported. |
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| Trouble Concentrating | Nervous system disorders | Reported mild trouble concentrating post-intervention as compared to pre-intervention. Most reported as tiredness. No long term trouble reported. |
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| Tiredness | Nervous system disorders | Reported mild tiredness post-intervention as compared to pre-intervention. |
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| Soreness | Musculoskeletal and connective tissue disorders | Participant reported mild soreness at the inferior frontal gyrus (stimulation site) post-stimulation. |
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| Blurry Vision | Eye disorders | Blurry vision reported after looking at computer screen for extended period of time |
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| Anxiousness | Psychiatric disorders | Reported increase in anxiety post-intervention |
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| Dizziness | Nervous system disorders | Reported mild dizziness post-intervention as compared to pre-intervention. |
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| Depression | Psychiatric disorders | Participant reported feeling mildly subdued/dazed/depressed following intervention. No long term effects. |
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| Achiness | Musculoskeletal and connective tissue disorders | Reported mild achiness post-intervention. |
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| Muscle Heaviness | Musculoskeletal and connective tissue disorders | Reported mild eye heaviness post-intervention. No long term effects. |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
|