Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 2 of 10 for:    Open Studies | Alzheimer's Disease | brain stimulation

Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Zhiqi Mao, Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Zhiqi Mao, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT03115814
First received: April 7, 2017
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
To investigate the safety of deep brain stimulation in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of deep brain stimulation in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function in patients with severe AD and dementia grading; to investigate the effects of deep brain stimulation on cerebral glucose metabolism in patients with severe AD.

Condition
Alzheimer Disease

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Deep Brain Stimulation for Treatment of Severe Alzheimer's Disease: Study Protocol of a Prospective, Self-control Phase I Trial

Resource links provided by NLM:


Further study details as provided by Zhiqi Mao, Chinese PLA General Hospital:

Primary Outcome Measures:
  • Deep brain stimulation-related disability rates [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]
    To assess the effectiveness of deep brain stimulation in the treatment of Alzheimer's disease (AD).


Secondary Outcome Measures:
  • Clinical Dementia Rating(CDR) score [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]
    The Clinical Dementia Rating(CDR) is 5-point scale used to characterize six domains (memory, orientation, judgment & problem solving, community affairs, home & hobbies and personal care) of the cognitive and functional performance of the aged (in particular AD patients). Patients are rated on dementia severity: 0 = normal, 0.5 = questionable dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia.

  • The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]
    The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) scale is widely used for evaluating the severity of AD. ADAS-Cog consists of 12 components including word recall, naming, command, constructional praxis, ideational praxis, orientation, word recognition, remembering test instructions, spoken language ability, word finding difficulty, comprehension of oral language, and attention. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. ADAS-Cog score ranges from 0-75, with higher scores indicating more severe cognitive impairment.

  • Mini-Mental State Examination (MMSE) score [ Time Frame: changes of baseline and month 1, month 6, month 12 after surgery ]
    Mini-Mental State Examination (MMSE) is one of the most influential cognitive screening tools worldwide. It consists of five dimensions including orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points) and language and praxis (9 points). Educational attainment level-related dementia classification: illiterate: 5 points ≤ MMSE score ≤16 points; primary school: 8 points ≤ MMSE score ≤ 20 points; junior high school and above: 10 points ≤ MMSE score ≤ 24 points.


Estimated Enrollment: 6
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Six Patients with severe Alzheimer's disease (AD) scheduled to receive deep brain stimulation will be all recruited from the clinics and wards of Department of Neurosurgery, Chinese PLA General Hospital of China.
Criteria

Inclusion Criteria:

  • Meet the diagnosis criteria of AD formulated by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
  • MMSE score 0-10 points;
  • Age 40-80 years;
  • Provision of signed informed consent.

Exclusion Criteria:

  • Abnormal brain structure prior to surgery (tumor, cerebral infarction, intracranial hematoma)
  • Complicated by other neurological system disorders, such as multiple sclerosis and epilepsy;
  • Psychiatric disorders, such as anxiety, depression or drug-induced psychosis;
  • Severe internal diseases, are taking respiratory system drugs, cardiovascular drugs, anticonvulsants or psychotropic drugs;
  • Inability to tolerance clinical complications;
  • Severe auditory and visual disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03115814

Contacts
Contact: Zhiqi Mao, Ph.D 8618910155994 markmaoqi@126.com

Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Zhiqi Mao, Ph.D Chinese PLA General Hospital
  More Information

Responsible Party: Zhiqi Mao, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03115814     History of Changes
Other Study ID Numbers: ChinaPLAGH_MZQ
Study First Received: April 7, 2017
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 25, 2017