AzTrials
AzTrials

Alzheimer's DiseaseNCT01504958

Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and NICE Cognitive Training in people with Alzheimer's Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Repetitive Transcranial Magnetic Stimulation (rTMS) and NICE Cognitive Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
Dec 2010to May 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 55-90
  • Diagnosed with mild to moderate AD according to DSM-IV criteria
  • Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
  • Normal or corrected normal ability to see and hear
  • Primary language is English

Who cannot join

  • IQ below 85
  • Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
  • Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
  • Any functional psychiatric disorder (eg. Schizophrenia)
  • Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
  • History of seizures, diagnosis of epilepsy
  • Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
  • Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

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.

Read the detailed description

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.

Being tested
Repetitive Transcranial Magnetic Stimulation (rTMS), NICE Cognitive Training
Keywords
Alzheimer's disease, Cognitive Training, Transcranial Magnetic Stimulation
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic Stimulation (rTMS)Device

    Also called Transcranial Magnetic Stimulation, Noninvasive Brain Stimulation

    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 TrainingBehavioural

    Also called Cognitive Training, Mental exercises

    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.

Study groups in NCT01504958
Study groupRoleWhat they receive
Active rTMS with real cognitive trainingActive comparatorHigh 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.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: NICE Cognitive Training
Sham rTMS with real cognitive trainingSham comparatorHigh 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.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: NICE Cognitive Training
Sham rTMS with sham cognitive trainingSham comparatorHigh 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.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: NICE Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Pre treatment; 1 month post treatment

Secondary outcomes (2)

  1. 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.

    Measured: Pre-treatment, 1 month post treatment

  2. 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.

    Measured: Pre-treatment, 1 month Post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504958
Sponsor's protocol ID
2010P000325
Status last verified
Jun 2017
First submitted
29 Sep 2011
Last updated
2 Jul 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 21246222

  • 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.

    PubMed 32733232

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and NICE Cognitive Training in people with Alzheimer's Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (time frame: Pre treatment; 1 month post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504958, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in