Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Device: TMS, H coil

• Registration Number: NCT01179373
• Lead Sponsor: Brainsway

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-08
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Primary Completion: 2015-01
• Study Completion: 2015-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS, Low Frequency	TMS, H coil	Low Frequency TMS to Prefrontal cortex
Sham Stimulation	TMS, H coil	Sham TMS with H Coil on Prefrontal Cortex
TMS, High Frequency	TMS, H coil	High Frequency TMS with H coil to prefrontal cortex

Primary Outcome Measures

Name	Time	Method
cognitive functioning score by ADAS-COG	4 months

Secondary Outcome Measures

Name	Time	Method
Global advancement score by CGI-C	4 months
Frontal lobe functioning score by FAB	4 months
Daily activity score by ADL	4 months

Trial Locations

Locations (1)

Merchav Clinics; 🇮🇱 Tel Aviv, Israel