Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263937
Other study ID # 13/0538
Secondary ID
Status Completed
Phase N/A
First received September 30, 2014
Last updated October 28, 2016
Start date January 2014
Est. completion date October 2016

Study information

Verified date October 2016
Source University College, London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

This trial aims to collect pilot data to explore whether bilateral deep brain stimulation (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking impairments among individuals with Dementia with Lewy Bodies (DLB).


Description:

We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM. We will place electrodes using our conventional image-guided, stereotactic frame-based procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in a crossover trial design to have 6 week periods of NBM stimulation switched on or switched off separated by a 2 week washout period, following which the patient will cross over to have the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and 14 weeks timepoints will be compared according to whether each patient was ON or OFF stimulation at that timepoint.

At the end of the crossover period, all patients will be invited for continued follow up with stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients will be given the option of receiving additional conventional stimulation to the motor GPi, through the higher contacts of each electrode, at the end of the crossover period if required for any coexisting Parkinsonian motor complications of DLB.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- DLB Consortium Criteria for diagnosis

- Score between 2 & 12 on Clinician Assessment of Fluctuations scale

- MMSE score between 21 and 27

- Appropriate Surgical candidates in terms of general health

- Aged between 50 & 80

- Able to give Informed consent

- Living at home with Carer

- Able to comply with protocol

- On stable dosage of cholinesterase inhibitor

Exclusion Criteria:

- Diagnosis of other cause for dementia

- Abnormality on brain imaging considered likely to compromise compliance with trial protocol.

- Prior intracerebral surgical intervention

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Bilateral Nucleus Basalis Meynert DBS
Low frequency stimulation applied using standard Deep brain stimualtion hardware.
Sham Nucleus Basalis Meynert DBS
DBS system switched off.

Locations

Country Name City State
United Kingdom UCL Institute of Neurology London
United Kingdom University of Newcastle Newcastle

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events Throughout trial period Yes
Primary Hopkins Verbal Learning test Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Primary Verbal Fluency Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Primary Simple & Choice Reaction time task Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Primary Wechsler Adult Intelligence scale (WAIS IV) Digit Span Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Primary Posner's Covert Attention test Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status No
Primary Clinician's Assessment of Fluctuations scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Minimental State Examination (MMSE) Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Dementia Rating Scale (DRS-2) Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Wechsler Abbreviated Scale of Intelligence (WASI) Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Short Recognition Memory Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Wechsler Adult Intelligence Scale IV -Letter, Number sequencing Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Trail Making test Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Stroop test Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Wechsler Adult Intelligence Scale IV - Symbol search Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Judgement of Line Orientation Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary North East Visual Hallucinations Interview Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Neuropsychiatric Inventory Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Florida Apraxia Screening test Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Clinical Global Impression Scale Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status No
Secondary Hamilton Depression scale Comparing ON v OFF at 6 weeks & 14 weeks according to stimulation status No
Secondary Hamilton Anxiety Scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Starkstein Apathy Rating scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Movement Disorders Society- Unified Parkinson's Disease Rating Scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Freezing of Gait- questionnaire Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Scales for outcome in Parkinson's disease (SCOPA - AUT) Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Quality of Life- Alzheimer's Disease Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Mayo Fluctuations Composite Scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Blessed Dementia scale Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Carer Strain Index Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
Secondary Short Form 36 Comparing ON v OFF stimulation at 6 weeks & 14 weeks according to stimulation status No
See also
  Status Clinical Trial Phase
Recruiting NCT03996460 - K0706 for Patients Diagnosed With Dementia With Lewy Bodies Phase 2
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Recruiting NCT02194816 - Modifiable Variables in Parkinsonism (MVP)
Active, not recruiting NCT01208675 - The Swedish BioFINDER Study
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Recruiting NCT03672448 - The China Longitudinal Aging Study of Cognitive Impairment
Completed NCT01340001 - Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies N/A
Not yet recruiting NCT04760860 - Terazosin for Dementia With Lewy Bodies Phase 1/Phase 2
Terminated NCT02928445 - Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension Phase 2/Phase 3
Completed NCT02910102 - Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia Phase 2
Terminated NCT02871427 - Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder Phase 2
Completed NCT05188105 - Alpha tACS in Dementia With Lewy Bodies N/A
Active, not recruiting NCT04167813 - Trial of Ondansetron as a Parkinson's HAllucinations Treatment Phase 2
Enrolling by invitation NCT04954183 - Development of an EEG Diagnostic for Alzheimer's Disease
Recruiting NCT05326750 - Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases N/A
Completed NCT01023672 - "Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies" Phase 4
Completed NCT03907748 - Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia N/A
Completed NCT04649164 - Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia N/A
Recruiting NCT03924414 - Trial of Parkinson's And Zoledronic Acid Phase 4
Completed NCT05885620 - SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia N/A