Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334450
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2011-04-12
Brief Title:
Transcranial Magnetic Stimulation TMS Treatment for Alzheimer Patients
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Deep-TMS for the Treatment of Alzheimer Disease Patients
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transcranial Magnetic Stimulation TMS for treatment of Alzheimer disease
Detailed Description:
Transcranial Magnetic Stimulation TMS for treatment of Alzheimer disease
Alzheimers disease AD is the leading cause of dementia and cognitive deteriorating in the advanced age The current medical treatment of AD is mainly symptomatic and has many limitation This main target of this study is to determine the safety and efficacy of transcranial magnetic stimulation TMS using novel coil design H2 for stimulation of deep brain structures concomitantly with regular treatment in Alzheimers disease AD patients TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor BDNF Hence it is postulated that TMS will have a positive effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the progression of the disease The treatment is non-invasive with no significant side effects and no need of hospitalization or anesthesia The trial is phase IIb double blind study including 45 AD patients ages between 50 to 80 with mild or moderate AD Mini Mental State Examination MMSE between 16 to 26 divided into 3 groups All participants will receive standard medical therapy for AD In addition patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions Patient will receive 3 treatments per week in the first 3 weeks and than 1 treatment per week for additional 4 weeks Patients will be evaluated before the treatments after 8 weeks of treatment and after another 8 weeks without treatment The evaluations will include cognitive function according to ADAS-COG and MMSE Activity of daily living ADL functions according to ADSC-ADL behavioral function according to the Neuropsychiatric Inventory NPI depression according to the Cornell Scale for Depression in Dementia CSDD care giver satisfaction according to the RUD LITE scale and computerized cognitive evaluation according to the NEXING battery We expect that the cognitive behavioral and ADL functions will improve better in the study group as compared to the Sham treated group From previous trial of TMS in neurological patients although not in AD we anticipate that adverse events rate will be similar between groups proving the safety of deep TMS treatment in patients with AD In case our hypothesis will be proven deep TMS treatment will be added as an important modality to the conventional therapy of AD patients
Alzheimers disease AD is the leading cause of dementia and cognitive deteriorating in the advanced age The current medical treatment of AD is mainly symptomatic and has many limitation This main target of this study is to determine the safety and efficacy of transcranial magnetic stimulation TMS using novel coil design H2 for stimulation of deep brain structures concomitantly with regular treatment in Alzheimers disease AD patients TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor BDNF Hence it is postulated that TMS will have a positive effect on the cognitive and behavioral symptoms of patients with AD and may ameliorated the progression of the disease The treatment is non-invasive with no significant side effects and no need of hospitalization or anesthesia The trial is phase IIb double blind study including 45 AD patients ages between 50 to 80 with mild or moderate AD Mini Mental State Examination MMSE between 16 to 26 divided into 3 groups All participants will receive standard medical therapy for AD In addition patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions Patient will receive 3 treatments per week in the first 3 weeks and than 1 treatment per week for additional 4 weeks Patients will be evaluated before the treatments after 8 weeks of treatment and after another 8 weeks without treatment The evaluations will include cognitive function according to ADAS-COG and MMSE Activity of daily living ADL functions according to ADSC-ADL behavioral function according to the Neuropsychiatric Inventory NPI depression according to the Cornell Scale for Depression in Dementia CSDD care giver satisfaction according to the RUD LITE scale and computerized cognitive evaluation according to the NEXING battery We expect that the cognitive behavioral and ADL functions will improve better in the study group as compared to the Sham treated group From previous trial of TMS in neurological patients although not in AD we anticipate that adverse events rate will be similar between groups proving the safety of deep TMS treatment in patients with AD In case our hypothesis will be proven deep TMS treatment will be added as an important modality to the conventional therapy of AD patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None