Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179373
• Other study ID #: 10003
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2010
• Last updated: January 24, 2018
• Start date: August 2010
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Description:

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Ages: 50-85 Genders: both

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Men and women aged 50-85.

2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).

3. Scored below 24 on the MMSE.

4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.

5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.

6. Gave their oral and written consent to participate in the trial.

Exclusion criteria:

1. An additional neurological or psychiatric disorder.

2. Severe personality disorder.

3. Uncontrolled hypertension.

4. History of epilepsy, seizure, or heat convulsion.

5. History of epilepsy or seizure in first degree relatives.

6. History of head injury or stroke.

7. History of metal implants in the head (except dental fillings).

8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.

9. History of migraines in the last six months.

10. History of drug or alcohol abuse.

11. Inadequate communication with examiner.

12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.

13. Inability to sign a consent form.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• TMS, H coil
TMS, H Coil, High/ Low Frequency

Locations

Country	Name	City	State
Israel	Merchav Clinics	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive functioning score by ADAS-COG		4 months
Secondary	Global advancement score by CGI-C		4 months
Secondary	Frontal lobe functioning score by FAB		4 months
Secondary	Daily activity score by ADL		4 months